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

NCT02503540 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2021-05-12

Study results available
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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.

Conditions

Interventions

DRUG

Aflibercept

Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.

Sponsors & Collaborators

Principal Investigators

  • Justis P Ehlers, MD · Cole Eye Institute, Cleveland Clinic, OH 44195

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-18
Primary Completion
2018-02-06
Completion
2018-02-06

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503540 on ClinicalTrials.gov