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Trial record 2 of 9 for:    Astellas Institute for Regenerative Medicine

A Phase 1b Dose Escalation Evaluation of Safety and Tolerability and a Phase 2 Proof of Concept Investigation of Efficacy and Safety of ASP7317 for Atrophy Secondary to Age-related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT03178149
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : September 27, 2018
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine )

Brief Summary:

The purpose of this study during the Dose Escalation stage is to assess the safety and tolerability of 3 ascending doses of ASP7317 in participants with age-related macular degeneration (AMD), of which one dose will be selected for evaluation of efficacy and safety during the Proof of Concept (PoC) stage of the study.

The primary purpose of the study during the PoC stage is to assess the safety, tolerability and superiority of ASP7317 at low cells/dose and the selected dose compared to untreated control and ASP7317 low cells/dose versus the selected dose in best corrected visual acuity (BCVA). This study will also assess safety by incidence of graft failure or rejection with a 13-week regimen of immunosuppression therapy.

Efficacy will also be assessed by the differences among ASP7317 at low cells/dose, ASP7317 at the selected dose and the untreated control group in other functional and structural parameters and patient reported outcomes during the PoC stage.

During the Extension stage this study will assess the safety and tolerability of ASP7317 at the most efficacious dose from PoC in participants randomized to the untreated control group.


Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: ASP7317 Other: Placebo Drug: tacrolimus Drug: mycophenolate mofetil (MMF) Phase 1 Phase 2

Detailed Description:

This is a two stage study followed by an extension stage. Stage 1 is a Phase 1b dose escalation evaluation of 3 doses of ASP7317; Stage 2 is Phase 2 Proof of Concept (PoC) investigation and Stage 3 is the extension stage which offers treatment options for participants randomized to the untreated control group in Stage 2.

During the dose escalation stage participants will be treated in each of the 3 dose cohorts (low cells/dose; medium cells/dose; high cells/dose). Doses will be administered to the study eye via a subretinal injection. Four weeks after the last participant in each dose cohort is treated, the independent Data Safety Monitoring Board (DSMB) will review data and images. Depending on the safety data there will be a recommendation to continue enrollment in the current cohort, or open enrollment for the next higher dose; stop dose escalation; investigate a lower dose or repeat a dose level.

The PoC stage will begin immediately following the decision of the Dose Escalation Committee (DEC) on the selected dose. Participants will be randomized in a 1:1:1 ratio to either the low cells/dose; the selected cells/dose or an untreated control group. Doses will be administered to the study eye via a subretinal injection for the low cells/dose and the selected cells/dose.

All participants treated with ASP7317 in the Dose Escalation and PoC stage will receive 13 weeks of immunosuppressive therapy (IMT) starting 1 week prior to day of transplant and continuing for 12 weeks post-transplant. If the primary outcome for PoC is demonstrated for the low cells/dose and the selected cells/dose then participants in the untreated control group who completed the 26 week visit are allowed to cross over to treatment with ASP7317 provided the participants remain suitable for immunosuppression therapy and ASP7317.

At the last study visit or time of withdrawal participants receiving ASP7317 will be consented to participate in the safety surveillance period of the study (under a separate protocol 7316-CL-0007), which will continue to monitor the participants for long-term safety via an annual questionnaire.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Staged Study Incorporating a Phase 1b, Multicenter, Unmasked, Dose Escalation Evaluation of Safety and Tolerability and a Phase 2, Multicenter, Unmasked, Randomized, Parallel Group, Controlled, Proof of Concept Investigation of Efficacy and Safety of ASP7317 for Atrophy Secondary to Age-related Macular Degeneration
Actual Study Start Date : July 13, 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : October 2026

Resource links provided by the National Library of Medicine

Drug Information available for: Tacrolimus

Arm Intervention/treatment
Experimental: ASP7317 Dose Escalation
Successive cohorts of participants (3 participants/ 3 cohort) will be treated in each escalating dose cohort (low cells/dose; medium cells/dose; high cells/dose). All participants in the low cells/dose and medium cells/dose cohorts may be treated simultaneously. The high cells/dose cohort will require sentinel dosing. After the first participant is dosed with high cells/dose and followed for 6 weeks the independent Data Safety Monitoring Board (DSMB) will review the safety data and images and recommend if the second and third participants may be treated with high cells/dose. One of the 3 doses will be selected for evaluation of efficacy and safety during the Proof of Concept (PoC) stage of the study. All participants will receive 13 weeks of immunosuppressive therapy (IMT) starting 1 week prior to day of transplant and continuing for 12 weeks posttransplant.
Drug: ASP7317
subretinal injection

Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf®

Drug: mycophenolate mofetil (MMF)
oral

Experimental: ASP7317 PoC Low Dose
Low cells/ dose will be administered to the study eye via a subretinal injection. All participants randomized to receive treatment with ASP7317 will receive 13 weeks of IMT starting 1 week prior to day of transplant and continuing for 12 weeks posttransplant.
Drug: ASP7317
subretinal injection

Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf®

Drug: mycophenolate mofetil (MMF)
oral

Experimental: ASP7317 PoC Selected Dose from Dose Escalation
Selected cells/ dose will be administered to the study eye via a subretinal injection. All participants randomized to receive treatment with ASP7317 will receive 13 weeks of IMT starting 1 week prior to day of transplant and continuing for 12 weeks posttransplant.
Drug: ASP7317
subretinal injection

Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf®

Drug: mycophenolate mofetil (MMF)
oral

Placebo Comparator: Placebo untreated group
Untreated participants with age-related macular degeneration (AMD)
Other: Placebo
no treatment

Experimental: ASP7317 Low Dose or Selected Dose Extension
If the primary endpoint for PoC is demonstrated for the selected cells/dose or low cells/dose of ASP7317, participants in the untreated control group, who completed the 26-week visit, will be allowed to cross over to treatment with ASP7317 in an extension stage of the protocol, provided the participant continues to meet eligibility criteria and are suitable for receiving IMT.
Drug: ASP7317
subretinal injection

Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf®

Drug: mycophenolate mofetil (MMF)
oral

Experimental: ASP7317 Safety Surveillance
Participants consented to participate in the safety surveillance will be monitored for the participants long term safety via an annual health questionnaire.
Drug: ASP7317
subretinal injection

Drug: tacrolimus
oral
Other Names:
  • FK506
  • Prograf®

Drug: mycophenolate mofetil (MMF)
oral




Primary Outcome Measures :
  1. PoC only: Change from baseline in BCVA score, measured by ETDRS method at week 26 [ Time Frame: Baseline and Week 26 ]
    Best corrected visual acuity (BCVA) will be measured by an assessor certified to use the early treatment of diabetic retinopathy study (ETDRS) method. The BCVA score (in logMAR units) will be reported.

  2. Safety as assessed by Incidence, frequency and severity of adverse events (AEs) [ Time Frame: Up to 60 Months ]
    Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Adverse event collection will begin upon the participant signing the informed consent.

  3. Safety as assessed by Incidence, frequency and severity of Serious adverse events (SAEs) [ Time Frame: Up to 60 Months ]
    An AE is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly or birth defect; requires inpatient hospitalization (except for planned procedures as allowed per study) or leads to prolongation of hospitalization (hospitalization for treatment/observation/examination caused by AE is to be considered as serious); or other medically important events.

  4. Safety as assessed by Incidence, frequency and severity of advanced therapy investigational medicinal product (ATIMP) events [ Time Frame: Up to 60 Months ]
    ATIMP events which may represent a significant hazard to the trial's participant population, and thus require expedited reporting, including but not limited to the following example ATIMPs: ectopic or proliferative cell growth (RPE or non-RPE) with adverse clinical Consequence; any new diagnosis of an immune-mediated disorder; any new cancer, irrespective of prior history; unexpected, clinically significant AEs possibly related to the cell transplant procedure, IMT or ASP7317 (e.g., graft failure or rejection).

  5. Number of Participants with graft failure or rejection [ Time Frame: Up to 60 Months ]
    Evidence of graft failure or rejection will be assessed by BCVA, slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.

  6. Incidence of graft failure or rejection [ Time Frame: Up to 60 Months ]
    Evidence of graft failure or rejection will be assessed by BCVA, slit lamp examination, dilated indirect ophthalmoscopy, fundus photographs, spectral domain-optical coherence tomography (SD-OCT) and fluorescein angiography (FA), when performed.

  7. Time of onset of ASP7317 to graft failure or rejection [ Time Frame: Up to 60 Months ]
    Immediate notification (within 24 hours of becoming aware) to the sponsor is required for any evidence of graft failure or rejection. AEs which are assessed as being evidence of graft failure or rejection will be summarized in additional AE tables, including time to onset relative to the start of adjunct study medication.

  8. Number of Participants with clinically significant changes in laboratory tests [ Time Frame: Up to 26 Weeks ]
    An abnormality identified during a medical test will be defined as an AE only if the abnormality meets 1 of the following criteria: induces clinical signs or symptoms; requires active intervention; requires interruption or discontinuation of adjunct study medications; age-related eye disease studies (AREDS) lens grade increase from baseline by ≥ 1 grade; the abnormality or test value is clinically significant; visual acuity loss of ≥ 10 letters due to graft failure or rejection.

  9. Number of Participants with clinically significant changes in blood pressure [ Time Frame: Up to 12 Weeks ]
    Clinically significant changes in blood pressure will be reported as moderate or severe.

  10. Number of Participants with clinically significant changes in anterior chamber (AC) cells grade [ Time Frame: Up to 26 Weeks ]
    Clinically significant changes in AC cells grade will be reported with a grade ranging from 0 to 4+ (0 = good and 4+ = not good), on a scale from <1 to >50, with cells in field as the indicator (0 = <1 cells in the field and 4+ = >50 cells in the field).

  11. Number of Participants with clinically significant changes in AC flare grade [ Time Frame: Up to 26 Weeks ]
    Clinically significant changes in flare grade will be reported with a grade ranging from 0 to 4+ and defined as follows: none (grade 0), faint (grade 1), moderate (iris and lens details clear, grade 2), marked (iris and lens details hazy, grade 3), and intense (fibrin or plastic aqueous, grade 4).

  12. Number of Participants with clinically significant changes in vitreous haze grade [ Time Frame: Up to 26 Weeks ]
    Clinically significant changes in vitreous haze grade will be reported with a grade ranging from 0 to 4+ and defined as follows: clear (grade 0), opacities without obstruction of retinal details (grade 1), few opacities resulting in the mild burning of posterior details of optic nerve and retinal vessels (grade 2), optic nerve head and retinal vessels significantly blurred but still visible (grade 3), dense opacity obscuring optic nerve head (grade 4).

  13. Number of Participants with clinically significant changes in intraocular pressure (IOP) in each eye [ Time Frame: Up to 60 Months ]
    Intraocular pressure in both eyes will be measured by tonometry. Intraocular pressure should be measured after biomicroscopic examination and before pupil dilation approximately the same time of day, when possible.


Secondary Outcome Measures :
  1. PoC only: Change from baseline in BCVA score, average of assessments from weeks 4 to 26 [ Time Frame: Baseline and up to Week 26 ]
    BCVA will be measured by an assessor certified to use the ETDRS method. The BCVA score (in logMAR units) will be reported.

  2. PoC only: Participant response, defined as a confirmed ≥ 10-letter (0.2 logMAR) improvement in BCVA, at week 26 [ Time Frame: Week 26 ]
    BCVA will be measured by an assessor certified to use the ETDRS method.

  3. PoC only: Change from baseline in mean retinal sensitivity of all test points in the index quadrant at week 26 [ Time Frame: Baseline and Week 26 ]
    The index quadrant is defined as the macular quadrant (superior, temporal, inferior or nasal) where ASP7317 is injected or, for the untreated control group, this is the macular quadrant recommended for ASP7317 injection by the subject selection committee (SSC).

  4. PoC only: Change from baseline in (square root) area of definite decreased autofluorescence (DDAF) in the index quadrant at week 26 [ Time Frame: Baseline and Week 26 ]
    DDAF will be assessed by Fundus Autofluorescence Photography (FAF). The image reading center will review the FAF images for area of DDAF and pattern of hyper autofluorescence around the DDAF.

  5. Change from baseline in the Functional Reading Independence Index (FRII) at week 26 [ Time Frame: Baseline and Week 26 ]
    The FRII is a 7-item questionnaire that evaluates the effect of geographic atrophy on a patient's ability to independently perform reading activities.

  6. Change from baseline in the Impact of Vision Impairment - Very Low Vision questionnaire (IVI-VLV) at week 26 [ Time Frame: Baseline and Week 26 ]
    The IVI-VLV questionnaire (28 questions) will be used to assess activities of daily living, mobility, safety and emotional well-being. This questionnaire measures perceived restriction of participation associated with daily living activities.



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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

General Inclusion Criteria:

  • Subject must be willing to take immunosuppressive therapy (IMT) and willing to discontinue any medication that has a known strong interaction with Prograf or MMF.
  • Subject should be in sufficiently good mental and physical health to reasonably be expected to complete the study to the week 26 visit.
  • Subject must have a score of ≤ 9 on the patient health questionnaire depression scale (PHQ-9) at the screening visit.
  • Subject who is taking an antidepressant must be on a stable and effective dosage and must be willing to take it reliably for as long as it is required.
  • Subject must be willing and medically suitable to undergo monitored anesthesia care during the transplant.
  • Subject is medically suitable to undergo vitrectomy and subretinal injection.
  • Subject agrees not to participate in another interventional study until the 26-week visit has been completed.
  • Pregnancy, breastfeeding, effective forms of birth control and ova/sperm donation criteria are specified in the clinical protocol and will be discussed with potential study subjects during the informed consent process.

Ocular Inclusion Criteria:

  • Subject has atrophy secondary to AMD in the study eye.
  • Subject has the border of the area of definite decreased autofluorescence (DDAF) in the study eye, within the vascular arcades.
  • Subject has a best corrected visual acuity (BCVA) score, in the study eye, at the second assessment during the screening visit between 4 and 23 early treatment diabetic retinopathy study (ETDRS) letters. In the dose escalation stage for the first dose cohort only, the study eye must be between light perception and ≤4 ETDRS letters at the second assessment during the screening visit.
  • Subject has stable BCVA, in the study eye, to ensure stability of the visual acuity measures for study analyses.
  • Subject has spectral domain-optical coherence tomography (SD-OCT) scans obtained of the study eye at the screening visit of suitable quality for grading retinal microstructures.
  • Subject, at the screening visit, must have in the study eye an area with reduced retinal function and evidence of structural retinal preservation between the border of the area of atrophy and the vascular arcades, as determined by the subject selection committee (SSC).
  • Subject is recommended by the SSC for trial participation.

Inclusion Criteria for Extension Stage 3:

  • Subject was previously enrolled as an untreated control subject in the PoC stage and completed the 26-week visit.
  • Subject is suitable to receive IMT and ASP7317 as determined by the SSC.

Exclusion Criteria:

- Subject is an employee of Astellas.

Ophthalmic Disease/Conditions:

The following conditions are exclusionary if present in the study eye, unless otherwise specified.

  • Subject has foveal sparing as determined by either of the following methods:

    • Loci in the fovea test grid with > 0 dB sensitivity based on microperimetry testing at the prescreening or screening visit assessments. The microperimetry testing procedures are specified in the Macular Integrity Assessment (MAIA™) microperimetry collection and submission instructions manual for the study.
    • Presence of potentially viable photoreceptors, as evidenced by presence of ellipsoid zone (EZ), ≤ 250 microns from the foveal center, based on reading center assessments at the screening visit.
  • Subject has evidence of prior or active choroidal neovascularization (CNV). Evidence of CNV will be assessed by the image reading center through review of the screening fundus photographs, fluorescein angiography (FA) and SD-OCT images. Evidence of CNV seen on 1 or more imaging modality is exclusionary.
  • Subject has macular atrophy due to causes other than AMD.
  • Subject has pathologic myopia defined as a spherical equivalent of > 8.00 diopters or axial length > 28 mm at the prescreening or screening visit, or myopic macular degeneration.
  • Subject has a contraindication to pupil dilation.
  • Subject has any other current sight-threatening ocular disease.
  • Subject has presence of a posterior staphyloma.
  • Subject has a current or prior history of optic neuropathy.
  • Subject has presence of a macular hole.
  • Subject has presence of macular schisis.
  • Subject has a current or prior history of retinal dystrophy, retinitis pigmentosa, chorioretinitis, central serous choroidopathy, diabetic retinopathy, diabetic macular edema, vasoocclusive disease or other retinal vascular disease (e.g., compromised blood-retinal barrier) or retinal degenerative disease other than AMD.
  • Subject has a prior history of retinal detachment within the vascular arcades.
  • Subject has presence of a choroidal nevus.
  • Subject has a history of dermal or oculodermal melanocytosis.
  • Subject has presence of submacular scarring.
  • Subject has presence of an ocular toxoplasmosis scar or suspected active infection (or presence of elevated immunoglobulin M [IgM] toxoplasmosis titer).
  • Subject has an abnormality of vitreoretinal interface (i.e., vitreomacular traction, epiretinal membranes, etc.) which can interfere with measurement of macular thickness or with the potential for macular structural damage.
  • Subject has an intraocular pressure (IOP) of < 6 mmHg or > 25 mmHg in either eye at the screening or first baseline (day -21) visits.
  • Subject has presence of glaucomatous optic atrophy or uncontrolled intraocular pressure (IOP) in either eye, or is using more than 2 agents to control IOP.
  • Subject has any history of uveitis.
  • Subject has any ocular inflammatory disease at time of the screening or first baseline (day -21) visits.
  • Subject has obscured ocular media opacity (e.g., corneal scars, lens opacities, vitreous abnormalities, etc.) at the screening or first baseline (day -21) visits such that reliable evaluations of the posterior segment cannot be performed.
  • Subject has any other current ocular condition that can interfere with the assessment of disease progression including but not limited to accumulation of intraretinal fluid, subretinal fluid, sub-retinal pigment epithelial/epithelium (RPE) fluid or cyctoid macular edema.
  • Subject has monocular vision.
  • Subject has a history of ocular cancer in either eye.

Other Medical Conditions:

  • Subject has a history of allergic reaction to fluorescein or inadequate venous access for FA.
  • Subject has a history of allergic reaction to sulfa drugs.
  • Subject is known to be seronegative and has been exposed to herpes zoster or varicella-zoster infection within 21 days prior to the start of IMT; or has a recurrent history of varicella-zoster virus infection.
  • Subject has a known history or clinical diagnosis of cytomegalovirus (CMV) infection within 6 weeks before start of IMT, or, in an individual who is known to be seronegative, exposure within 21 days prior to the start of IMT; recurrent history of CMV infection.
  • Subject has received a solid organ or bone marrow transplant.
  • Subject has an active, extraocular infection requiring the prolonged or chronic use of antimicrobial or antiinfective agents.
  • Subject has a current malignancy or a history of malignancy within the previous 5 years, including myelodysplastic syndrome, central nervous system lymphoma; with the exception of nonmetastatic basal or squamous cell carcinoma of the skin or carcinoma-in-situ of the cervix that has been treated successfully.
  • Subject has a history of familial adenomatous polyposis.
  • Subject has a positive cancer screening test(s), defined as any abnormality requiring investigation to rule out malignant neoplasm or other pathology that could jeopardize the safety of the subject or impact the subject's ability to comply with the study visit schedule. Tests must be performed if the subject has not been performed within the timeframes (relative to the screening visit) indicated below:

    • Dermatological examination for malignant skin lesions within previous 6 months.
    • Stool-based or serological testing for detection of colorectal cancer within previous 3 months.
    • Colonoscopy within previous 10 years, unless more frequent evaluation is clinically indicated.
    • If male, prostate specific antigen test (with or without digital rectal exam) within previous 12 months.
    • If female and 65 years of age or younger, pelvic examination with Papanicolaou smear within previous 3 years
    • If female mammogram within previous 12 months.
    • Chest X-ray (posteroanterior and lateral views) taken on or within the previous 3 months if known or suspected history of cardiopulmonary disease.
    • If there is any family history of any malignant disorder that has known familial association, then the subject's current cancer status for that disorder must be investigated as per direction from the sponsor's medical monitor.
  • Subject has a history of myocardial infarction in previous 12 months.
  • Subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease or a family history of long QT syndrome.
  • Subject has a mean Fridericia-corrected QT interval (QTcF) of > 430 ms (for males) and > 450 ms (for females) at screening. If the mean QTcF exceeds the limits above, 1 additional triplicate electrocardiogram (ECG) can be taken.
  • Subject has any abnormality in Electrocardiogram (ECG) results that is clinically significant and could eitherjeopardize the safety of the subject, impact the subject's ability to comply with study visit schedule or impact the validity of the study results.
  • Subject has a study day systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 95 mmHg, at either the screening or first baseline (day -21) visit.
  • Subject has a history of uncontrolled diabetes mellitus.
  • Subject has any condition that would prohibit the use of systemic immunosuppression with Prograf and MMF.
  • Subject has inflammatory bowel disease (e.g., clinically diagnosed irritable bowel syndrome, Crohn's disease, ulcerative colitis).
  • Subject has a positive tuberculosis (TB) test during the screening period by positive purified protein derivative within 72 hours of placement of test, by an interferon gamma release assay (e.g., QuantiFERON) or by the institution's standard testing procedure. If a subject has tested negative for TB within the 6 months prior to the screening visit, retesting is not required unless clinically indicated.
  • Subject has a history of or current condition that will interfere with the subject's ability to comply with the protocol, compromise subject safety or interfere with the interpretation of the study results (e.g., cognitive impairment, dementia, active substance abuse, uncontrolled psychiatric disorder or elective treatment).

Prior and Concomitant Ocular Therapies:

The following conditions are exclusionary if present in the study eye, if applicable.

  • Subject has received prior treatment with anti-vascular endothelial growth factor (VEGF) (for any indication) within 12 weeks prior to the screening visit or anticipated use at any point during the study.
  • Subject has received prior intravitreal treatment other than anti-VEGF treatment.
  • Subject has undergone intraocular surgery or refractive surgery within 12 weeks prior to the screening visit.
  • Subject is anticipated to require ocular surgery prior to completing the 26-week visit or any ocular treatment, which could confound the efficacy results or affect subject compliance with the visit schedule.
  • Subject has any history of an ocular implant, with the exception of an intraocular lens.
  • Subject has undergone prior retinal surgery involving the macula, vitrectomy, macular laser photocoagulation, external-beam radiation therapy, transpupillary thermotherapy, glaucoma filtration surgery or corneal surgery (except cataract surgery).

Prior and Concomitant Therapy:

  • Subject has received gene transfer or cell transplant therapy in a prior clinical trial.
  • Subject has participated within 12 weeks prior to the screening visit in any clinical trial of a drug by ocular or systemic administration and/or has not recovered from any reversible effects or side effects of a prior investigational agent.
  • Subject has received any IMT (other than topical, inhaled or low-dose systemic corticosteroid use not exceeding 7.5 mg of prednisone daily [or equivalent]) within 26 weeks prior to the screening visit.
  • Subject is unwilling to discontinue the following medications while taking Prograf: more than 3 days of continuous dosing with a nonsteroidal antiinflammatory drug (with the exception of aspirin, 75 to 325 mg total daily dose, used for cardiac prophylaxis, which is allowed), azoles, diltiazem, verapamil, nicardipine, rifampin, phenobarbital, phenytoin, carbamazepine, direct Factor Xa inhibitors, direct thrombin inhibitors, St. John's wort and amiodarone.
  • Subject is unwilling to discontinue the following medications while the subject is taking MMF: ganciclovir, valganciclovir and cholestyramine; however, valganciclovir may be initiated as needed for treatment of CMV in conjunction with a reduction (or discontinuation) in MMF dose.

Clinical Laboratory Tests:

The following are exclusionary if observed at the screening visit.

  • Subject has any abnormality in blood chemistry, urinalysis or hematology results that is clinically significant and prohibits participation in the study.
  • Subject has an estimated glomerular filtration rate (eGRF) of ≤ 50 mL/min, calculated by the chronic kidney disease epidemiology collaboration (CKD-EPI) equation.
  • Subject has a spot urine protein to creatinine ratio or spot urine albumin to creatinine ratio > 0.3.
  • Subject has an alanine aminotransferase (ALT), aspartate aminotransferase (AST) or gamma-glutamyltransferase (GGT) and total bilirubin (TBL) ≥ 2 times the upper limit of normal (ULN).
  • Subject has severe anemia (hemoglobin < 9 g/dL [male] or hemoglobin < 8 g/dL [female]), leucopenia (white blood cell count < 2500/mm3), thrombocytopenia (platelet count < 80000/mm3) or polycythemia (hematocrit > 54% [male] or hematocrit > 49% [female]).
  • Subject has a hemoglobin A1c > 7.0%.
  • Subject has a clinically significant coagulopathy (i.e., activated partial thromboplastin time [aPTT] ≥ 1.5 times the ULN and/or prothrombin time adjusted for the international normalized ratio [PT-INR] ≥ 2.0).
  • Subject has a positive serology test for syphilis or Lyme disease.
  • Subject has a positive serology test for human immunodeficiency virus (HIV), active hepatitis A, B, or C virus (HAV, HBV, HCV) or varicella-zoster virus (subjects who have been vaccinated against HAV, HBV or varicella-zoster are eligible to participate).
  • Subject has a positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, opiates, cocaine, cannabinoids, phencyclidine and methadone), unless the drug is taken for a documented medical condition and u

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03178149


Contacts
Contact: Astellas Institute for Regenerative Medicine 800-888-7704 astellas.registration@astellas.com

Locations
United States, California
Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
United States, Florida
Retina Specialty Institute Recruiting
Pensacola, Florida, United States, 35203
United States, New Jersey
NJ Retina Recruiting
New Brunswick, New Jersey, United States, 08901
United States, Pennsylvania
Mid-Atlantic Retina Recruiting
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Astellas Institute for Regenerative Medicine
Investigators
Study Director: Global Therapeutic Area Head & Chief Medical Officer Astellas Institute for Regenerative Medicine

Responsible Party: Astellas Institute for Regenerative Medicine
ClinicalTrials.gov Identifier: NCT03178149     History of Changes
Other Study ID Numbers: 7317-CL-0003
2016-005099-87 ( EudraCT Number )
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: September 27, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Astellas Pharma Inc ( Astellas Institute for Regenerative Medicine ):
Age-related Macular Degeneration
ASP7317

Additional relevant MeSH terms:
Physiological Effects of Drugs
Macular Degeneration
Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Tacrolimus
Mycophenolic Acid
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents