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
|Condition or disease||Intervention/treatment||Phase|
|Retinal Vein Occlusion Diabetic Macular Edema Branch Retinal Vein Occlusion Central Retinal Vein Occlusion||Drug: Aflibercept||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Monthly aflibercept for 6 months and then every other month for 6 months.
Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
Other Name: Eylea
- 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)
- Mean change in total leakage index [ Time Frame: 6 months ]
- Diabetic retinopathy severity (if applicable) [ Time Frame: 6 and 12 months ]
- Amount hemorrhage [ Time Frame: 6 and 12 months ]
- Change in ischemic index (defined as the proportion of retinal area with nonperfusion) [ Time Frame: 6 and 12 months ]
- Mean absolute change from baseline central subfield thickness [ Time Frame: 6 and 12 months ]
- Mean change from baseline in best-corrected visual acuity (BCVA) score [ Time Frame: 6 and 12 months ]
- Percentage of subjects that were anatomically 'dry' by SDOCT [ Time Frame: 6 and 12 months ]
- Percentage of participants who gained or lost 10 letters or more of vision [ Time Frame: 6 and 12 months ]
- Percentage of subjects who gained or lost 15 letters or more of vision [ Time Frame: 6 and 12 months ]
- Percentage of patients that are 20/40 or better [ Time Frame: 6 and 12 months ]
- Percentage of patients that are 20/200 or worse [ Time Frame: 6 and 12 months ]
- Incidence and severity of ocular and non-ocular adverse events (AEs) and serious AEs. [ Time Frame: 6 and 12 months ]
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
|United States, Ohio|
|Cole Eye Institute, Cleveland Clinic|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Justis P Ehlers, MD||Cole Eye Institute, Cleveland Clinic, OH 44195|