Peripheral and Macular Retinal Vascular Perfusion and Leakage in DME and RVO

Phase 4

Completed

• Conditions: Diabetic Macular Edema; Retinal Vein Occlusion; Branch Retinal Vein Occlusion; Central Retinal Vein Occlusion
• Interventions: Drug: Aflibercept

• Registration Number: NCT02503540
• Lead Sponsor: Justis Ehlers

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 optical coherence tomography (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.

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, vascular endothelial growth factor (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 Timeline

• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-20
• Study First Posted: 2015-07-21
• Study Start: 2015-08-18
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Results First Submitted: 2020-01-29
• Results First Submitted QC: 2020-01-29
• Results First Posted: 2020-02-12
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-10
• Last Update Posted: 2021-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept	Aflibercept	Monthly aflibercept for 6 months and then every other month for 6 months.

Primary Outcome Measures

Name	Time	Method
Change in Panretinal Leakage Index at Month 12 From Baseline	12 months	Change in panretinal leakage index (defined as the proportion of retinal area involved in angiographic leakage) at month 12 from baseline as measured by ultra-widefield angiography (UWFA).

Secondary Outcome Measures

Name	Time	Method
Mean Change in Total Leakage Index	6 months	Mean change in total leakage index from baseline to month 6
Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) Score Based on ETDRS	12 months	Mean change from baseline in best-corrected visual acuity (BCVA) score from baseline to month 12
Change in Panretinal Ischemic Index	12 months	Change in panretinal ischemic index from baseline to postoperative month 12
Number of Patients That Showed Visual Acuity 20/40 or Better	12 months
Number of Patients That Showed Visual Acuity 20/200 or Worse	12 months
Number of Patients Who Gained 15 ETDRS Letters or More of Vision	6 months
Ocular Serious Adverse Events	12 months
Change in Panretinal Ischemic Index From Baseline at 6 Months	6 months	Change in panretinal ischemic index (defined as the proportion of retinal area with nonperfusion) from baseline at 6 months
Mean Change From Baseline Central Subfield Thickness	12 months
Number of Participants Who Gained 15 ETDRS Letters or More of Vision	12 months
Number of Participants Who Lost 15 ETDRS Letters or More of Vision	6 months
Systemic Serious Adverse Events	12 Months	Incidence of systemic SAEs

Trial Locations

Locations (1)

Cole Eye Institute, Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States