Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

Part of paid clinical trials in Houston, Texas.

Sponsor
Greater Houston Retina Research
Study ID
NCT03531294
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The PRIME trial will assess the safety of 2 mg intravitreal aflibercept injections (IAI) to achieve and maintain DRSS improvements (2 or more steps) in patients with a baseline DRSS level of 47A to 71A inclusive through 104 weeks as determined by reading center determined DRSS gradings on OPTOS fundus photos and leakage index on OPTOS WF-FA.

Key Dates

Start date
May 23, 2018
Status verified
May 2021
Primary completion
Apr 9, 2021
Completion
Apr 9, 2021

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1
    Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based on OPTOS funds photos.
  • Experimental: Group 2
    Treatment based on central reading center reading evaluation of DRSS (diabetic retinopathy severity scale) level based leakage index of OPTOS wide field fluorescein angiography.

Primary Outcome Measure

Incidence of Adverse Events for diabetic retinopathy subjects who receive intravitreal Aflibercept [ Time Frame: 104 weeks ]

Locations (2)

FacilityCityStateZIPSite coordinators
Retina Consultants of Houston/The Medical CenterHoustonTexas77030-
Retina Consultants of HoustonThe WoodlandsTexas77384-

Find similar trials in Houston, TX

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Consultants of Houston/The Medical Center· Houston, TXRetina Consultants of Houston· The Woodlands, TX

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