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

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.

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu de Poitiers

Poitiers, 86021, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

Primary outcomes

Number of intravitreal injections of ranibizumab

Time frame: 1 years

Secondary outcomes

best-corrected visual acuity

Time frame: 1 years

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Apr 4, 2013
Registry last updated: Mar 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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