Targeted Laser in Diabetic Macular Edema

NCT03751501 | Completed DMC

• 1 other identifier: P18-01
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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

Conditions

Macular Edema; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (2)

• Number of anti VEGF injections

  as measured between baseline and M12

  12months

• Change in Visual Acuity (Letters)

  As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)

  12 months

Secondary Outcomes (5)

• Change in central macular thickness

  12 months

• Cost of treatment

  12 months

• Incremental cost-utility ratio

  12 months

• Impact on quality of life using standard score evolution

  12 months

• Number of AEs/SAEs

  36 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

Indocyanine green-Guided Targeted Laser photocoagulation combines routine procedures, that are, the detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT. Indocyanine green-Guided Targeted Laser photocoagulation is administered in combination with anti VEGF treatment

Procedure: Indocyanine green-Guided Targeted Laser photocoagulation

Control Group

SHAM COMPARATOR

Sham laser is administered at randomization visit and repeated if needed 3 month later in combination with anti VEGF treatment

Procedure: Sham laser

Interventions

Indocyanine green-Guided Targeted Laser photocoagulation PROCEDURE

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

Experimental Group

Sham laser PROCEDURE

Therapeutic procedure used in ophthalmology

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts: lead

Study Sites (1)

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Paris, 75012, France

Location

Related Publications (1)

• Dupas B, Castro-Farias D, Girmens JF, Eginay A, Couturier A, Villeroy F, Delyfer MN, Creuzot-Garcher C, Giocanti-Auregan A, Beral L, Arndt C, Mesnard C, Vicaut E, Chaumet-Riffaud P, Durand-Zaleski I, Paques M. Photocoagulation or sham laser in addition to conventional anti-VEGF therapy in macular edema associated with TelCaps due to diabetic macular edema or retinal vein occlusion (TalaDME): a study protocol for a multicentric, French, two-group, non-commercial, active-control, observer-masked, non-inferiority, randomized controlled clinical trial. Trials. 2024 Apr 22;25(1):273. doi: 10.1186/s13063-024-07994-1.

  PMID: 38649937 DERIVED

MeSH Terms

Conditions

Macular Edema; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Michel PAQUES, PU-PH

  Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomized into one of the 2 study arms groups: "standard of care" group with sham laser or experimental group with laser. Both group with laser or sham laser will be performed in combination with anti VEGF treatment

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 23, 2018
• Study Start: February 12, 2019
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: May 4, 2025

Record last verified: 2023-12

Locations

FR (1)