Targeted Laser in Diabetic Macular Edema

NCT03751501 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2025-05-04

No results posted yet for this study

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 in patients with diabetic macular edema without adverse consequences for visual acuity.

Conditions

Interventions

PROCEDURE

Indocyanine green-Guided Targeted Laser photocoagulation

Detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.

PROCEDURE

Sham laser

Therapeutic procedure used in ophthalmology

Sponsors & Collaborators

  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    lead OTHER

Principal Investigators

  • Michel PAQUES, PU-PH · Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-12
Primary Completion
2024-12-11
Completion
2024-12-11

Countries

  • France

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03751501 on ClinicalTrials.gov