Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
- Sponsor
- Poitiers University Hospital
- Study ID
- NCT01823965
- Phase
- PHASE2
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 79 Years
- Healthy Volunteers
- Not accepted
Interventions
- ranibizumab — DRUG
Study Details
In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.
Key Dates
- First listed
- Apr 4, 2013
- Start date
- Oct 31, 2011
- Status verified
- Mar 2016
- Primary completion
- Jul 31, 2014
- Completion
- Jul 31, 2014
Study Design
- Enrollment
- 35 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: ranibizumab
Primary Outcome Measure
Number of intravitreal injections of ranibizumab [ Time Frame: 1 years ]
Related Studies
- Phase I Study to Assess the Safety and Efficacy of OCU200 for Center-Involved Diabetic Macular Edema (DME)PHASE1 · Recruiting · Ocugen · Deerfield Beach, Florida
- EC-104 Intravitreal Implant for the Treatment of Diabetic Macular EdemaPHASE1/PHASE2 · Recruiting · Eclipse Life Sciences, Inc. · Tampa, Florida
- Intranasal Delivery of Octreotide for Treatment of Diabetic Macular EdemaPHASE1 · Not Yet Recruiting · University of Alabama at Birmingham · Birmingham, Alabama
- Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)PHASE2 · Recruiting · Sierra Eye Associates · Reno, Nevada