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Targeted Laser in Diabetic Macular Edema (TaLa-DME)

Primary Purpose

Macular Edema, Diabetic Retinopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Indocyanine green-Guided Targeted Laser photocoagulation
Sham laser
Sponsored by
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Experimental Group

    Control Group

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    Number of anti VEGF injections
    as measured between baseline and M12
    Change in Visual Acuity (Letters)
    As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)

    Secondary Outcome Measures

    Change in central macular thickness
    as measured between baseline and M12
    Cost of treatment
    as measured between baseline and M12
    Incremental cost-utility ratio
    as measured between baseline and M12
    Impact on quality of life using standard score evolution
    as measured between baseline and M12
    Number of AEs/SAEs
    as measured between baseline and M36

    Full Information

    First Posted
    November 20, 2018
    Last Updated
    November 21, 2018
    Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03751501
    Brief Title
    Targeted Laser in Diabetic Macular Edema
    Acronym
    TaLa-DME
    Official Title
    Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 22, 2018 (Anticipated)
    Primary Completion Date
    October 24, 2019 (Anticipated)
    Study Completion Date
    October 24, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Macular Edema, Diabetic Retinopathy

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    270 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Group
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    Control Group
    Arm Type
    Sham Comparator
    Arm Description
    Sham laser is administered at randomization visit and repeated if needed 3 month later in combination with anti VEGF treatment
    Intervention Type
    Procedure
    Intervention Name(s)
    Indocyanine green-Guided Targeted Laser photocoagulation
    Intervention Description
    Detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.
    Intervention Type
    Procedure
    Intervention Name(s)
    Sham laser
    Intervention Description
    Therapeutic procedure used in ophthalmology
    Primary Outcome Measure Information:
    Title
    Number of anti VEGF injections
    Description
    as measured between baseline and M12
    Time Frame
    12months
    Title
    Change in Visual Acuity (Letters)
    Description
    As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Change in central macular thickness
    Description
    as measured between baseline and M12
    Time Frame
    12 months
    Title
    Cost of treatment
    Description
    as measured between baseline and M12
    Time Frame
    12 months
    Title
    Incremental cost-utility ratio
    Description
    as measured between baseline and M12
    Time Frame
    12 months
    Title
    Impact on quality of life using standard score evolution
    Description
    as measured between baseline and M12
    Time Frame
    12 months
    Title
    Number of AEs/SAEs
    Description
    as measured between baseline and M36
    Time Frame
    36 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hayet Serhane
    Phone
    0140021144
    Ext
    +33
    Email
    hserhane@15-20.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michel Paques
    Organizational Affiliation
    Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Targeted Laser in Diabetic Macular Edema

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