CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Bevacizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03246152
NCT03246152Phase 4Completed

Evaluation of the Effect of Repeated Intravitreal Injections of Anti-VEGF on Macular Perfusion in Diabetic Patients Using Optical Coherence Tomography Angiography

Cairo University·interventional·Posted Aug 11, 2017·Updated Jan 30, 2020

In Brief

A Phase 4 clinical trial evaluating Bevacizumab for Diabetic Macular Edema and Ischemic Maculopathy. Completed, enrolled 31 participants across 1 site.

Detailed Summary

Anti-vascular endothelial growth factor (VEGF) drugs are the mainstay of therapy for diabetic macular edema (DME), substantially improving visual acuity for many diabetics worldwide, and proving effective for treatment of both non-proliferative and proliferative diabetic retinopathy. Many studies such as Diabetic Retinopathy Clinical Research Network studies, RESTORE Study, and The BOLT Study have supported the use of different anti-VEGF agents in the treatment of DME with better visual outcomes using anti-VEGF injections alone or in combination with other treatments. Several ocular complications of intravitreal anti-VEGF injections have been reported including endophthalmitis, cataract and retinal detachment. The effect of anti-VEGF drugs on macular perfusion has been inconclusive, with mixed reports of increase, decrease or no effect on perfusion in response to anti-VEGF treatment. In many of these studies, however, patients with more ischaemic retinas were not included. Retinal ischemia is an important factor in the progression and prognosis of diabetic retinopathy. Fluorescein angiography (FA) was the method used to assess changes in macular perfusion after anti-VEGF injections in most of the studies. Despite its clinical usefulness, however, FA is known to have documented risks. Optical coherence tomography angiography (OCTA) is a new noninvasive method of acquiring high-resolution images of the retinal vasculature that can be utilized in the treatment of retinal disease without the need for dye injection. It allows the visualization of the superficial and deep retinal capillary layers separately and the construction of microvascular flow maps. Several studies have proved the reliability of OCTA in detecting and quantifying macular ischemia in diabetics. In this study, investigators aim to evaluate the effect of repeated intravitreal injections of different Anti-VEGF agents on the perfusion of different capillary layers in the macula of diabetic patients using OCTA.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesEgypt
Collaborators--

Timeline

Phase 4CompletedFinished
201820192020202120222023202420252026
First PostedAug 11, 2017
Enrollment StartOct 23, 2017
Primary CompletionDec 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.9 years ago

Interventions

Bevacizumabdrug

Repeated intravitreal injections of Bevacizumab monthly