Retinal TelangiectasisPhase 3COATS-VEGFNCT03940690
Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
A Phase 3 study testing Anti-VEGF injections of bevacizumab and Laser in people with Retinal Telangiectasis and Coats Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites in France.
Trial summary
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Retinal Telangiectasis, Coats Disease
- What is being tested?
- Anti-VEGF injections of bevacizumab and Laser
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 6 sitesFrance
- Study dates
- 24 Oct 2019to 13 Oct 2023
- Phase
- Phase 3
- 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 Up to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stage 2 or 3 at the fundus (Shields classification)
- Naive to any eye treatment on the eye affected by Coats disease
Who cannot join
- Other ocular pathology on the eye affected by Coats' disease
- Bilateral forms of the disease
- History of hypersensitivity to bevacizumab
- History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
- Allergic reaction in a previous fluorescein retinal angiogram
- Pregnancy or breastfeeding
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- Active or suspected periocular infection
- Contraindication to treatments used for general anesthesia and morphine derivatives
- Cardiovascular, haemorrhagic and gastrointestinal risks
- Premature baby who has not reached the correct age of 37 weeks
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
CHU de Bordeaux
Bourdeaux, 33076
Centre hospitalier René Dubos (Pontoise)
Cergy-Pontoise, France, 95303
Hôpital Universitaire Necker Enfants Malades, APHP
Paris, France, 75015
Fondation Ophtalmologique A. de Rothschild
Paris, France, 75019
CHU de Reims
Reims, France, 51092
Clinique Rive Gauche
Toulouse, France, 31000
About this study
Official title: Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.
The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.
- Conditions
- Retinal Telangiectasis, Coats Disease
- Being tested
- Anti-VEGF injections of bevacizumab, Laser
- Keywords
- Retinal Telangiectasis, Coats Disease, Anti-VEGF (Vascular Endothelial Growth Factor)
- Medical subject headings
- Retinal Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-VEGF injections of bevacizumabDrug
5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9)
LaserDevice
3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9
| Study group | Role | What they receive |
|---|---|---|
| Anti-VEGF injections (bevacizumab) | Experimental | 5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9 Receives: Drug: Anti-VEGF injections of bevacizumab |
| Arm : laser only | Active comparator | 3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9 Receives: Device: Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with improvement of stage of disease, according to the Shields classification
Stages assessed by retinal multimodal imaging (retinophotography, optical coherence tomography when age allows, retinal fluorescein angiography) by two independent expert ophthalmologists
Measured: 6 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start24 Oct 2019
- Primary completion6 Jun 2023
- Study completion13 Oct 2023
Why it stopped: Study futility based on the interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal TelangiectasisStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Florence METGE, Principal investigator, fmetge@for.paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940690
- Sponsor's protocol ID
- FME_2018_9
- Acronym
- COATS-VEGF
- Status last verified
- Dec 2025
- First submitted
- 6 May 2019
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Controlled Trial on the Interest of Intravitreal Injections of Anti-VEGF as Initial and Adjuvant Treatment in Coats Disease
- ClinicalTrials.gov ID
- NCT03940690
- Acronym / sponsor ID
- COATS-VEGF / FME_2018_9
- Conditions
- Retinal Telangiectasis, Coats Disease
- Keywords
- Retinal Telangiectasis, Coats Disease, Anti-VEGF (Vascular Endothelial Growth Factor)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study futility based on the interim analysis
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 6 Jun 2023 (actual)
- Study completion
- 13 Oct 2023 (actual)
- First posted
- 7 May 2019 (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.
Coats disease is a predominantly unilateral progressive retinal vascular disease, characterized by retinal telangiectasias with intra- or subretinal exudate deposits, which can lead to retinal detachment and one-sided blindness. Several treatment modalities are available and the choice of one of them depends on the stage of the disease and the habits of each center (laser photocoagulation, cryotherapy ...). VEGF (Vascular Endothelial Growth Factor) was found to be significantly elevated in the aqueous humor and subretinal fluid of patients with Coats disease. Several studies have shown the potential efficacy of intra-vitreous injections of anti-VEGF. But the results on their effectiveness have been evaluated only on small series of patients. Most published studies have analyzed their efficacy combined with another treatment, mainly laser photocoagulation. The true efficacy of anti-VEGF therapy as initial therapy, and then combined in Coats disease remains unknown. Currently, several centers are initiating first-line anti-VEGF injections, although no rigorous evaluation of this therapeutic strategy has been conducted.
The identification of the best treatment regimen will allow in the future the reduction of laser reprocessing and will ensure a better functional benefit in the affected patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anti-VEGF injections (bevacizumab) | Experimental | Drug: Anti-VEGF injections of bevacizumab5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9 |
| Arm : laser only | Active comparator | Device: Laser3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9 |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Coats disease confirmed by fundus examination and fluorescein angiography
- Stage 2 or 3 at the fundus (Shields classification)
- Naive to any eye treatment on the eye affected by Coats disease
Key exclusion criteria (10 listed)
- Other ocular pathology on the eye affected by Coats' disease
- Bilateral forms of the disease
- History of hypersensitivity to bevacizumab
- History of hypersensitivity to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies
- Allergic reaction in a previous fluorescein retinal angiogram
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 |
|---|---|---|
| Anti-VEGF injections of bevacizumab5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9) | Drug | Anti-VEGF injections (bevacizumab) |
| Laser3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9 | Device | Arm : laser only |
Primary outcome
Proportion of patients with improvement of stage of disease, according to the Shields classification
Time frame: 6 months after randomization
Stages assessed by retinal multimodal imaging (retinophotography, optical coherence tomography when age allows, retinal fluorescein angiography) by two independent expert ophthalmologists
Results and safety
The study was stopped early (reason given: Study futility based on the interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Florence METGE principal investigator
fmetge@for.paris
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anti-VEGF injections of bevacizumab and Laser in people with Retinal Telangiectasis and Coats Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 6 sites 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 3 inclusion and 10 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: stopped early, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study futility based on the interim analysis). Results are not available in the source record.
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?
Proportion of patients with improvement of stage of disease, according to the Shields classification (time frame: 6 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.