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Targeted Laser in Diabetic Macular Edema (TaLa-DME)

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ClinicalTrials.gov Identifier: NCT03751501
Recruitment Status : Not yet recruiting
First Posted : November 22, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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.

Condition or disease Intervention/treatment Phase
Macular Edema Diabetic Retinopathy Procedure: Indocyanine green-Guided Targeted Laser photocoagulation Procedure: Sham laser Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

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

Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"
Estimated Study Start Date : November 22, 2018
Estimated Primary Completion Date : October 24, 2019
Estimated Study Completion Date : October 24, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of anti VEGF injections [ Time Frame: 12months ]
    as measured between baseline and M12

  2. Change in Visual Acuity (Letters) [ Time Frame: 12 months ]
    As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)


Secondary Outcome Measures :
  1. Change in central macular thickness [ Time Frame: 12 months ]
    as measured between baseline and M12

  2. Cost of treatment [ Time Frame: 12 months ]
    as measured between baseline and M12

  3. Incremental cost-utility ratio [ Time Frame: 12 months ]
    as measured between baseline and M12

  4. Impact on quality of life using standard score evolution [ Time Frame: 12 months ]
    as measured between baseline and M12

  5. Number of AEs/SAEs [ Time Frame: 36 months ]
    as measured between baseline and M36



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03751501


Contacts
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Contact: Hayet Serhane 0140021144 ext +33 hserhane@15-20.fr

Sponsors and Collaborators
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Investigators
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Principal Investigator: Michel Paques Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

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Responsible Party: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
ClinicalTrials.gov Identifier: NCT03751501     History of Changes
Other Study ID Numbers: P18-01
First Posted: November 22, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Edema
Macular Edema
Retinal Diseases
Diabetic Retinopathy
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases