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
About this trial
This is an interventional prevention trial for Macular Edema
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
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
NCT ID
NCT03751501
First Posted
November 20, 2018
Last Updated
November 21, 2018
Sponsor
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
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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