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Trial record 70 of 81 for:    CRVO - Central Retinal Vein Occlusion

Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO (PERMEATE)

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ClinicalTrials.gov Identifier: NCT02503540
Recruitment Status : Completed
First Posted : July 21, 2015
Last Update Posted : March 19, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Justis Ehlers, The Cleveland Clinic

Brief Summary:
This interventional study will evaluate the retinal vascular dynamics associated with Intravitreal Aflibercept Injection (IAI) therapy in eyes with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO). Ultra-widefield fluorescein angiography and OCT angiography will be performed at multiple timepoints to assess the changes in retinal vascular leakage, ischemia, and vascular abnormalities throughout the study duration and compare these alterations to baseline.

Condition or disease Intervention/treatment Phase
Retinal Vein Occlusion Diabetic Macular Edema Branch Retinal Vein Occlusion Central Retinal Vein Occlusion Drug: Aflibercept Phase 4

Detailed Description:

Diabetic macular edema (DME) and macular edema secondary to retinal venous occlusive diseases are the most common cause of vision loss from a retinal vascular disease. Recently VEGF inhibitors (bevacizumab, aflibercept, and ranibizumab) have been described as new first-line therapies for these conditions. Aflibercept is the most recently approved VEGF inhibitor for the management of these conditions. Clinical trials have shown that treatment with aflibercept improves visual acuity and reduces macular edema in a large percentage of patients.

This study will examine the changes that occur with intravitreal aflibercept to perfusion and leakage in treatment naive eyes over the course of 1 year.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Peripheral and Macular Retinal Vascular Perfusion and Leakage Dynamics in Diabetic Macular Edema and Retinal Venous Occlusions During Intravitreal Aflibercept Injection (IAI) Treatment for Retinal Edema: PERMEATE Study
Actual Study Start Date : August 18, 2015
Actual Primary Completion Date : February 6, 2018
Actual Study Completion Date : February 6, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Aflibercept
Monthly aflibercept for 6 months and then every other month for 6 months.
Drug: Aflibercept
Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Other Name: Eylea




Primary Outcome Measures :
  1. Mean change in total leakage index [ Time Frame: 12 months ]
    mean change in total leakage index at month 12 as measured by ultra-widefield angiography (defined as the proportion of retinal area involved in angiographic leakage)


Secondary Outcome Measures :
  1. Mean change in total leakage index [ Time Frame: 6 months ]
  2. Diabetic retinopathy severity (if applicable) [ Time Frame: 6 and 12 months ]
  3. Amount hemorrhage [ Time Frame: 6 and 12 months ]
  4. Change in ischemic index (defined as the proportion of retinal area with nonperfusion) [ Time Frame: 6 and 12 months ]
  5. Mean absolute change from baseline central subfield thickness [ Time Frame: 6 and 12 months ]
  6. Mean change from baseline in best-corrected visual acuity (BCVA) score [ Time Frame: 6 and 12 months ]
  7. Percentage of subjects that were anatomically 'dry' by SDOCT [ Time Frame: 6 and 12 months ]
  8. Percentage of participants who gained or lost 10 letters or more of vision [ Time Frame: 6 and 12 months ]
  9. Percentage of subjects who gained or lost 15 letters or more of vision [ Time Frame: 6 and 12 months ]
  10. Percentage of patients that are 20/40 or better [ Time Frame: 6 and 12 months ]
  11. Percentage of patients that are 20/200 or worse [ Time Frame: 6 and 12 months ]
  12. Incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs. [ Time Frame: 6 and 12 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

A subject must meet the following criteria to be eligible for inclusion in the study:

  1. Signed Informed Consent.
  2. Men and women ≥ 18 years of age.
  3. Foveal-involving retinal edema secondary to DME or RVO based on investigator review of SDOCT.
  4. E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye or Hand Motion (HM) in the study eye.
  5. Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
  6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form.

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from the study:

  1. Any prior or concomitant therapy with another investigational agent to treat DME or RVO in the study eye.
  2. Prior panretinal photocoagulation in the study eye.
  3. Prior intravitreal anti-VEGF therapy in the study eye.
  4. Prior focal/grid laser photocoagulation in the study eye.
  5. Prior history of intravitreal steroid therapy in the study eye.
  6. Any history of allergy to fluorescein sodium or other reason that the patient is unable to undergo fluorescein angiography (e.g., inability to get vascular access, unable to tolerate procedure)
  7. Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up to 3 months prior to first dose, and will not be allowed during the study.
  8. Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery as determined by the investigator on clinical exam and ultra-widefield angiography.
  9. Presence of other causes of macular edema, including myopic degeneration, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal neovascularization, neovascular age-related macular degeneration or multifocal choroiditis in the study eye. Epiretinal membranes are allowed.
  10. Presence of macula-threatening traction retinal detachment.
  11. Prior vitrectomy in the study eye.
  12. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
  13. Any history of macular hole of stage 2 and above in the study eye.
  14. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of day 1, as long as it's unlikely to interfere with the injection.
  15. Prior trabeculectomy or other filtration surgery in the study eye.
  16. Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg despite treatment with anti-glaucoma medication) in the study eye.
  17. Active intraocular inflammation in either eye.
  18. Active ocular or periocular infection in either eye.
  19. Any ocular or periocular infection within the last 2 weeks prior to Screening in either eye.
  20. Any history of uveitis in either eye.
  21. Active scleritis or episcleritis in either eye.
  22. Presence or history of scleromalacia in either eye.
  23. Aphakia in the study eye.
  24. Previous therapeutic radiation in the region of the study eye.
  25. History of full-thickness penetrating keratoplasty in the study eye. Partial thickness corneal transplants including DSAEK and DMEK are allowed.
  26. Significant media opacities, including cataract, in the study eye which might interfere with visual acuity, assessment of safety, or fundus photography.
  27. Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the opinion of the investigator, could require either medical or surgical intervention during the 52 week study period.
  28. Any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
  29. Participation as a subject in any clinical study within the 12 weeks prior to Day 1.
  30. Any systemic therapy with an investigational agent in the past 3 months prior to Day 1.
  31. Any history of allergy to povidone iodine.
  32. Pregnant or breast-feeding women
  33. Women of childbearing potential* who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

    • Postmenopausal women must be amenorrheic for at least 12 months in order not to be considered of child bearing potential. Pregnancy testing and contraception are not required for women with documented hysterectomy or tubal ligation.

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): NCT02503540


Locations
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United States, Ohio
Cole Eye Institute, Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Justis Ehlers
Regeneron Pharmaceuticals
Investigators
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Principal Investigator: Justis P Ehlers, MD Cole Eye Institute, Cleveland Clinic, OH 44195

Publications:
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Responsible Party: Justis Ehlers, Assistant Professor of Ophthalmology, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT02503540     History of Changes
Other Study ID Numbers: 15-442
First Posted: July 21, 2015    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Justis Ehlers, The Cleveland Clinic:
macular edema
rvo
diabetic macular edema

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Degeneration
Retinal Diseases
Venous Thrombosis
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases