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Clinical Trials/NCT01823965
NCT01823965
Completed
Phase 2

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

Poitiers University Hospital1 site in 1 country35 target enrollmentOctober 2011

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.

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
July 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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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