Targeted Laser in Diabetic Macular Edema (TaLa-DME)

November 21, 2018 updated by: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 in patients with DME.

Acts which are the subject of the study: indocyanine green-Guided Targeted Laser photocoagulation (IGTL): this 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.

Study act: the treatment study includes a baseline laser treatment (experimental group) or sham laser (control group) at randomization, repeated if needed 3 month later, administered in combination with anti VEGF treatment, consisting of 3 monthly injections in the first 3 months, and a maintenance phase with monthly visits where retreatment is administered as needed through a PRN regimen, based on morphological (retinal thickness on OCT) and functional (visual acuity) criteria.

To evaluate the interest of IGTL in real conditions, the choice of the anti VEGF treatment used for intravitreal injection (Ranibizumab or Aflibercept, which have French marketing authorizations) is left to each investigator (equivalent therapeutic efficacy). Bevacizumab is ruled out due to its lower efficacy compared with Aflibercept among eyes with worse baseline VA, that represent the majority of the patients in our study. In addition, bevacizumab is currently off-label in France for DME If both eyes are eligible at the time of randomization, only one eye will be included and analyzed. However, the fellow eye will be treated with the randomization-assigned treatment and the testing will be performed on each eye.

Risks and constraints involved in the study: these procedures are commonly done in ophthalmology care settings; no additional risk is expected due to the study.

Expected benefits for the participants and for the company: These procedures are commonly done in ophthalmology care settings; no additional risk is expected due to the study.

Study Type

Interventional

Enrollment (Anticipated)

270

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Group
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
Detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.
Sham Comparator: Control Group
Sham laser is administered at randomization visit and repeated if needed 3 month later in combination with anti VEGF treatment
Procedure: Sham laser
Therapeutic procedure used in ophthalmology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of anti VEGF injections
Time Frame: 12months
as measured between baseline and M12
12months
Change in Visual Acuity (Letters)
Time Frame: 12 months
As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in central macular thickness
Time Frame: 12 months
as measured between baseline and M12
12 months
Cost of treatment
Time Frame: 12 months
as measured between baseline and M12
12 months
Incremental cost-utility ratio
Time Frame: 12 months
as measured between baseline and M12
12 months
Impact on quality of life using standard score evolution
Time Frame: 12 months
as measured between baseline and M12
12 months
Number of AEs/SAEs
Time Frame: 36 months
as measured between baseline and M36
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Investigators

  • Principal Investigator: Michel PAQUES, Centre hospitalier National d'Ophtalmologie des Quinze-Vingts

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 22, 2018

Primary Completion (Anticipated)

October 24, 2019

Study Completion (Anticipated)

October 24, 2021

Study Registration Dates

First Submitted

November 20, 2018

First Submitted That Met QC Criteria

November 21, 2018

First Posted (Actual)

November 23, 2018

Study Record Updates

Last Update Posted (Actual)

November 26, 2018

Last Update Submitted That Met QC Criteria

November 21, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P18-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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