Status:
COMPLETED
Targeted Laser in Diabetic Macular Edema
Lead Sponsor:
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Conditions:
Macular Edema
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Our hypothesis is that implementing laser photocoagulation (IGTL) as an adjunctive treatment to intravitreal injections should lead to a significant reduction in the need for intravitreal injections i...
Detailed Description
This study will be French, multicenter parallel group, 2-arms, randomized, sham laser-controlled, double-blind trial evaluating the effect of IGTL as an adjunctive procedure to intravitreal injections...
Eligibility Criteria
Inclusion
- Diabetic women and men ≥18 years
- with visual acuity lower or equal than 20/32 ( ≤ 74 TaLaDME protocol\_v1.2\_12.07.2018 9/76 ETDRS letters)
- with central retinal thickness of more than 300μm in Spectral Domain OCT (SD-OCT) and/or presence of retro-foveal hard exudates
- due to DME
- with one or more macro-aneurysms with a diameter greater than 150 μm in the posterior pole
- with health insurance
- who signed the written informed consent form
Exclusion
- Presence of age-related drusens or of a macular degeneration in one or both any eyes
- Significant opacity of the ocular media that could contribute to decreased visual acuity
- macro-aneurysm(s) mainly responsible for the DME located less than 500μm from the center of the fovea (i.e. within 1 disc radius of the fovea),
- Steroids injection within the last 4 months
- proliferative diabetic retinopathy requiring panretinal photocoagulation or associated with posterior tractional retinal detachment that may be worsened by the use of anti-VEGF therapy
- myocardial infarction or stroke within the last 3 months
- Cataract surgery within the last 3 months
- Local treatment with prostaglandin
- Women who are pregnant, breast feeding or of child bearing age without effective contraception
Key Trial Info
Start Date :
February 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2024
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT03751501
Start Date
February 12 2019
End Date
December 11 2024
Last Update
May 4 2025
Active Locations (1)
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1
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, France, 75012