Macular EdemaTaLa-DMENCT03751501
Targeted Laser in Diabetic Macular Edema
A study testing Indocyanine green-Guided Targeted Laser photocoagulation in people with Macular Edema and Diabetic Retinopathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Diabetic Retinopathy
- What is being tested?
- Indocyanine green-Guided Targeted Laser photocoagulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- 12 Feb 2019to 11 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
About this study
Official title: 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.
Read the 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.
- Conditions
- Macular Edema, Diabetic Retinopathy
- Being tested
- Indocyanine green-Guided Targeted Laser photocoagulation, Sham laser
- Medical subject headings
- Macular Edema, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green-Guided Targeted Laser photocoagulationProcedure or surgery
Detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.
Sham laserProcedure or surgery
Therapeutic procedure used in ophthalmology
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Sham laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of anti VEGF injections
as measured between baseline and M12
Measured: 12months
Change in Visual Acuity (Letters)
As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)
Measured: 12 months
Secondary outcomes (5)
Change in central macular thickness
as measured between baseline and M12
Measured: 12 months
Cost of treatment
as measured between baseline and M12
Measured: 12 months
Incremental cost-utility ratio
as measured between baseline and M12
Measured: 12 months
Impact on quality of life using standard score evolution
as measured between baseline and M12
Measured: 12 months
Number of AEs/SAEs
as measured between baseline and M36
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start12 Feb 2019
- Primary completion11 Dec 2024
- Study completion11 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PAQUES, PU-PH, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03751501
- Sponsor's protocol ID
- P18-01
- Acronym
- TaLa-DME
- Status last verified
- Dec 2023
- First submitted
- 20 Nov 2018
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dupas B, Castro Farias D, Querques G, Forte P, Girmens JF, Couturier A, Erginay A, Delyfer MN, Paques M; TelCaps Study Group. Islets persisting on OCT macular thickness map after intravitreal injections unmask telangiectatic capillaries (TelCaps) in diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2026 May;264(5):1287-1296. doi: 10.1007/s00417-025-07095-y. Epub 2026 Jan 26.
PubMed 41586917Dupas 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.
PubMed 38649937
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Photocoagulation of Capillary Macro-aneurysms in Addition to the Standard Treatment of Macular Edema Due to Diabetic Retinopathy. "TaLa_DME"
- ClinicalTrials.gov ID
- NCT03751501
- Acronym / sponsor ID
- TaLa-DME / P18-01
- Conditions
- Macular Edema, Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 11 Dec 2024 (actual)
- First posted
- 23 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Procedure: Indocyanine green-Guided Targeted Laser photocoagulationIndocyanine 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 |
| Control Group | Sham comparator | Procedure: Sham laserSham laser is administered at randomization visit and repeated if needed 3 month later in combination with anti VEGF treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indocyanine green-Guided Targeted Laser photocoagulationDetection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT. | Procedure or surgery | Experimental Group |
| Sham laserTherapeutic procedure used in ophthalmology | Procedure or surgery | Control Group |
Primary outcome
Number of anti VEGF injections
Time frame: 12months
as measured between baseline and M12
Change in Visual Acuity (Letters)
Time frame: 12 months
As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)
5 secondary outcomes
Change in central macular thickness
Time frame: 12 months
Cost of treatment
Time frame: 12 months
Incremental cost-utility ratio
Time frame: 12 months
Impact on quality of life using standard score evolution
Time frame: 12 months
Number of AEs/SAEs
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41586917Dupas B, Castro Farias D, Querques G, Forte P, Girmens JF, Couturier A, Erginay A, Delyfer MN, Paques M; TelCaps Study Group. Islets persisting on OCT macular thickness map after intravitreal injections unmask telangiectatic capillaries (TelCaps) in diabetic macular edema. Graefes Arch Clin Exp Ophthalmol. 2026 May;264(5):1287-1296. doi: 10.1007/s00417-025-07095-y. Epub 2026 Jan 26.
- Derived from this study: PubMed 38649937Dupas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel PAQUES, PU-PH principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green-Guided Targeted Laser photocoagulation in people with Macular Edema and Diabetic Retinopathy, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of anti VEGF injections (time frame: 12months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03751501, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.