Targeted Laser in Diabetic Macular Edema

Diabetic Retinopathy Clinical Trial

— TaLa-DME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03751501
• Other study ID #: P18-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 22, 2018
• Est. completion date: October 24, 2021

Study information

• Verified date: November 2018
• Source: Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
• Contact: Hayet Serhane
• Phone: 0140021144
• Email: hserhane[@]15-20.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: October 24, 2021
• Est. primary completion date: October 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Edema
• Macular Edema
• Retinal Diseases

Intervention

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 laser
Therapeutic procedure used in ophthalmology

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of anti VEGF injections	as measured between baseline and M12	12months
Primary	Change in Visual Acuity (Letters)	As measured by the Early Treatment Diabetic Retinopathy Study (ETDRS)	12 months
Secondary	Change in central macular thickness	as measured between baseline and M12	12 months
Secondary	Cost of treatment	as measured between baseline and M12	12 months
Secondary	Incremental cost-utility ratio	as measured between baseline and M12	12 months
Secondary	Impact on quality of life using standard score evolution	as measured between baseline and M12	12 months
Secondary	Number of AEs/SAEs	as measured between baseline and M36	36 months