Ranibizumab in Residual Diabetic Macular Edema Following Previous Anti-VEGF Therapy

Part of paid clinical trials in Worcester, Massachusetts.

Sponsor
Vitreo-Retinal Associates, PC
Study ID
NCT01472510
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
  • Ranibizumab — DRUG
    A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection

Study Details

This study is designed to confirm that the investigational drug Ranibizumab given by injection into the eye is safe and effective to use in people with diabetic macular edema (DME).

Key Dates

First listed
Nov 16, 2011
Start date
Dec 31, 2011
Status verified
Mar 2014
Primary completion
Jul 31, 2013
Completion
Jan 31, 2014

Study Design

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

Arms

  • Active Comparator: Arm 1:The PRN Group
    You will receive 6 monthly intravitreal injections of 0.5% Ranibizumab administered about every 28 days. It is possible you may receive additional injections into the study eye for the next six months if certain criteria is met.
  • Active Comparator: arm 2:The Monthly Group:
    You will receive 12 monthly intravitreal injections of 0.5% Ranibizumab administered every 28 days.

Primary Outcome Measure

Change in Visual Acuity Scores at Month 12 Compared to Baseline [ Time Frame: 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Vitreo-Retinal Associates, PCWorcesterMassachusetts01605-

Find similar trials in Worcester, MA

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Vitreo-Retinal Associates, PC· Worcester, MA

Related Studies