NCT03751501Completed
Targeted Laser in Diabetic Macular Edema
Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"
Source: ClinicalTrials.gov · Last updated 4 May 2025
Brief summary (registry, in English)
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 in patients with diabetic macular edema without adverse consequences for visual acuity.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 270 (actual)
- First submitted
- 20 Nov 2018
- Start date
- 12 Feb 2019
- Primary completion date
- 11 Dec 2024
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Diseases
- Diabetic eye disease
- NCT number
- NCT03751501
What you commit to
- Study type: Interventional
- Participants enrolled: 270
- From 12 Feb 2019 to the primary completion date, 11 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Cataract surgery within the last 3 months
- Local treatment with prostaglandin
Other illness
- myocardial infarction or stroke within the last 3 months
Age
- Presence of age-related drusens or of a macular degeneration in one or both any eyes
- Women who are pregnant, breast feeding or of child bearing age without effective contraception
Other
- 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),
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier National D'ophtalmologie Des Quinze Vingts Coordinator of this site? Confirm its status | Paris | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.