Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Part of paid clinical trials in Clearwater, Florida.

Sponsor
Retina Vitreous Associates of Florida
Study ID
NCT01476449
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Ranibizumab — DRUG
    Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
  • Ranibizumab — DRUG
    Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.

Study Details

This study is to see whether treating diabetic retinal swelling with ranibizumab injections into the eye monthly is better than treating diabetic retinal swelling with ranibizumab injections into the eye less frequently.

Key Dates

First listed
Nov 22, 2011
Start date
Nov 30, 2011
Status verified
Apr 2019
Primary completion
Sep 30, 2016
Completion
Sep 30, 2016

Study Design

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

Arms

  • Active Comparator: Monthly Ranibizumab
    Patients randomized to the Monthly Ranibizumab arm of the study will be administered intravitreal injections each month for their diabetic macular edema for the duration of the study.
  • Experimental: Treat and Extend Ranibizumab
    Patients randomized to this arm of the study will receive intravitreal injections of ranibizumab until their maculae are anatomically "dry," at which point the evaluation and injection interval will be extended.

Primary Outcome Measure

Mean Change in Early Treatment for Diabetic Retinopathy Study (ETDRS) Eye Chart Vision. [ Time Frame: Baseline through 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Retina Vitreous Associates of FloridaClearwaterFlorida33756-
Retina Vitreous Associates of FloridaSt. PetersburgFlorida33711-

Find similar trials in Clearwater, FL

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Retina Vitreous Associates of Florida· Clearwater, FLRetina Vitreous Associates of Florida· St. Petersburg, FL

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