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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Justis Ehlers
Study ID
NCT02503540
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Aug 18, 2015
Status verified
May 2021
Primary completion
Feb 6, 2018
Completion
Feb 6, 2018

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Aflibercept
    Monthly aflibercept for 6 months and then every other month for 6 months.

Primary Outcome Measure

Change in Panretinal Leakage Index at Month 12 From Baseline [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Cole Eye Institute, Cleveland ClinicClevelandOhio44195-

Find similar trials in Cleveland, OH

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Cole Eye Institute, Cleveland Clinic· Cleveland, OH

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