NCT01823965
Completed
Phase 2
Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
Overview
- Phase
- Phase 2
- Intervention
- ranibizumab
- Conditions
- Diabetic Macular Edema
- Sponsor
- Poitiers University Hospital
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Number of intravitreal injections of ranibizumab
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •diabetes mellitus (1 or2)
- •decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity\<69 letters using E.T.D.R.S testing)
- •macular edema
Exclusion Criteria
- •history of severe cardiac disease
- •stroke within 12 months
- •intraocular inflammation
Arms & Interventions
ranibizumab
Intervention: ranibizumab
Outcomes
Primary Outcomes
Number of intravitreal injections of ranibizumab
Time Frame: 1 years
Secondary Outcomes
- best-corrected visual acuity(1 years)
Study Sites (1)
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