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Trial record 1 of 1 for:    NCT03465709
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APL-2 in Neovascular AMD

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ClinicalTrials.gov Identifier: NCT03465709
Recruitment Status : Active, not recruiting
First Posted : March 14, 2018
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Apellis Pharmaceuticals, Inc.

Brief Summary:
Safety Assessment of APL-2 in Patients with Neovascular AMD

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: APL-2 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An 18-Month Phase Ib/II Multi-Center, Open Label Study to Evaluate the Safety of Intravitreal APL-2 Therapy in Patients With Neovascular Age-Related Macular Degeneration (AMD)
Actual Study Start Date : January 24, 2018
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: APL-2 Study Drug Drug: APL-2
Study Drug




Primary Outcome Measures :
  1. Safety outcome: Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events [ Time Frame: duration of study (18 months) ]
    Incidence and Severity of Ocular and Systemic Treatment-Emergent Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age greater than or equal to 60 years.
  2. Normal Luminance best corrected visual acuity (NL-BCVA) of 24 letters or better using Early Treatment Diabetic Retinopathy Study (ETDRS) charts (20/320 Snellen equivalent).
  3. Clinical diagnosis of neovascular AMD with the following criteria met:

    1. Eligible for an injection of an anti-VEGF injection with macular fluid present at Day -28.
    2. Must have been treated with anti-VEGF in study eye for at least 6 months prior to joining the study.
    3. At least 6 months of intravitreal anti-VEGF therapy at intervals not greater than 8 weeks (± 7 days) for the past 2 injections in the eye that is selected to be the study eye.
  4. A clinically meaningful (50%) reduction in excess macular fluid or macular thickness in the study eye at the discretion of the investigator between Screening Day -28 and Screening Day -14 as assessed by SD-OCT.
  5. Female subjects must be:

    1. Women of non-child-bearing potential (WONCBP), or
    2. Women of child-bearing potential (WOCBP) with a negative pregnancy test at screening and must agree to use protocol defined methods of contraception for the duration of the study and refrain from breastfeeding for the duration of the study.
  6. Males with female partners of child-bearing potential must agree to use protocol defined methods of contraception and agree to refrain from donating sperm for the duration of the study.
  7. Willing and able to give informed consent and to comply with the study procedures and assessments

Exclusion Criteria:

  1. Presence of other causes of choroidal neovascularization (CNV) including pathologic myopia (spherical equivalent ≥ -6 diopters), central serous chorioretinopathy, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis.
  2. History of vitrectomy to the study eye
  3. Presence of any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the Investigator, interferes with ophthalmologic examination (e.g. advanced cataract or corneal abnormalities).
  4. Intraocular surgery (including lens replacement surgery) within 3 months prior to randomization.
  5. Any history of endophthalmitis.
  6. Trabeculectomy or aqueous shunt or valve in the study eye.
  7. Aphakia or absence of the posterior capsule. Note: previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to baseline.
  8. Any ophthalmic condition that may require surgery or medical intervention during the study period or, in the opinion of the Investigator, could compromise visual function during the study period (e.g. severe uncontrolled glaucoma, clinically significant diabetic macular edema, ischemic optic neuropathy, retinal vasculopathies).
  9. Any contraindication to IVT injection including current ocular or periocular infection.
  10. Current treatment for active systemic or localized infection.
  11. Participation in any systemic experimental treatment or any other systemic investigational new drug within 6 weeks or 5 half-lives of the active (whichever is longer) prior to the start of study treatment. Note: clinical trials solely involving observation, over-the-counter vitamins, supplements, or diets are not exclusionary
  12. Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the 24- month treatment period unlikely, or would make the subject an unsafe study candidate.
  13. Any baseline laboratory value (hematology, serum chemistry or urinalysis) that in the opinion of the Investigator is clinically significant and not suitable for study participation.
  14. Known hypersensitivity to fluorescein sodium for injection or hypersensitivity to APL-2 or any of the excipients in APL-2 solution

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): NCT03465709


Locations
United States, California
Apellis Clinical Site
Beverly Hills, California, United States, 90211
United States, Maryland
Apellis Clinical Site
Hagerstown, Maryland, United States, 21740
United States, Texas
Apellis Clinical Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Apellis Pharmaceuticals, Inc.

Responsible Party: Apellis Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT03465709     History of Changes
Other Study ID Numbers: APL2-203
First Posted: March 14, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 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

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases