Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment

Phase 2

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: ranibizumab

• Registration Number: NCT01823965
• Lead Sponsor: Poitiers University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2013-03-27
• Study First Submitted QC: 2013-04-03
• Study First Posted: 2013-04-04
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-29
• Last Update Posted: 2016-03-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ranibizumab	ranibizumab	-

Primary Outcome Measures

Name	Time	Method
Number of intravitreal injections of ranibizumab	1 years

Secondary Outcome Measures

Name	Time	Method
best-corrected visual acuity	1 years

Trial Locations

Locations (1)

Chu de Poitiers; 🇫🇷 Poitiers, France