Macular TelangiectasiaPhase 3TELeMACNCT03845049
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
A Phase 3 study testing Inclusion examinations, Aflibercept Injection [Eylea] and Examinations during study (every month) in people with Macular Telangiectasia, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Idiopathic juxtafoveal telangiectasia type 1 is a rare unilateral disease that mostly affects men before 50 years of age. Mac Tel 1 are characterized by microvascular telangiectasia and increased tortuosity of the macular capillary network on the temporal part of the fovea that can be identified on fundus examination. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Telangiectasia
- What is being tested?
- Inclusion examinations, Aflibercept Injection [Eylea] and Examinations during study (every month)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jul 2019to 26 Mar 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient who have given their written informed consent
- Patient major
- Patient with idiopathic macular telangiectasia type 1 identified at least 4 months previously, with or without peripheral exudative abnormalities
- Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCT images
- Patient with best-corrected ETDRS visual acuity between strictly24 and 79 letters
- Patient meeting at least 1 of the following criteria:
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- Patient naive to any treatment
- Patient with a contraindication for laser photocoagulation
- Patient with persistence of macular edema after treatment with anti-VEGF (including aflibercept) administered more than 4 months previously
- Patient with persistence of macular edema after laser photocoagulation treatment more than 4 months previously
- Patient with persistence of macular edema after treatment with corticosteroids administered more than 6 months previously
- Patient with an assessment by the treating ophthalmologist that focal coagulation (for both groups) and anti-VEGF treatment (for the placebo group) could be safely deferred for 6 months
- Woman of childbearing potential (WOCBP)* must commit to consider and use an efficient method of birth control during the trial and at least 3 months after the last aflibercept/SHAM administration
Who cannot join
- Patient not affiliated to a national health insurance scheme
- Patient subject to a measure of legal protection (guardianship, tutorship)
- Patient subject to a court order
- Patient pregnant, parturient or nursing women (WOCBP)*
- Patient incapable of expressing consent
- Patient with edema linked to conditions other than macular telangiectasia (namely retinal vein occlusion, diabetic retinopathy, ocular ischemic syndrome, sickle-cell anemia, maculopathy, hypertensive retinopathy…)
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- Patient presenting any cardiovascular eventwithin 6 months before inclusion
- Poor media clarity, which can prevent adequate fundus imaging
- Patient with hypersensitivity to the active substance (aflibercept) or to any of the excipients of EYLEA®
- Patient with active or suspected ocular or periocular infection or severe active intraocular inflammation.
- Any history of allergy to the antiseptic used during preparation of the eye for the IVT injection in the investigational site (e.g. povidone iodine or chlorhexidine).
Trial locations and contacts
1 site in 1 country.
About this study
Idiopathic juxtafoveal telangiectasia type 1 is a rare unilateral disease that mostly affects men before 50 years of age. Mac Tel 1 are characterized by microvascular telangiectasia and increased tortuosity of the macular capillary network on the temporal part of the fovea that can be identified on fundus examination. It can be associated with peripheral vascular changes, similar to manifestations of Coats' disease. It can be complicated by macular edema due to leakage from microvascular ectasia. When associated with visual loss, macular edema can be treated with different strategies although there is no consensus about the best approach. Laser can be performed on leaky aneurysms with questionable long term efficacy and potential irreversible adverse effects. Recently, anti-VEGF agents have been put forward as particularly good candidates to treat this macular edema, as observed in vein occlusion or diabetic macular edema. Indeed, in limited case series, the first anti-VEGF agents (ranibizumab and bevacizumab) showed mitigated results. More recently, authors have reported some favorable results with aflibercept in patients refractory to other anti-VEGF agents. Indeed a recent study reported both good anatomical and functional results in macular edema due to Mac Tel 1 in a non-comparative study that included 8 patients and carried out a concomitant quantification of growth factors. As an explanation, the authors found that levels of placental growth factor (PlGF), which is targeted by aflibercept but not by other anti-VEGF agents, were decreased after treatment. Moreover, PlGF correlated with capillary plexus densities assessed by OCTA. The aim of this study is thus to assess the efficacy of a 6 months treatment by aflibercept compared to placebo in macular edema linked to Mac Tel 1 with a multicenter double-blind randomized clinical trial.
- Conditions
- Macular Telangiectasia
- Being tested
- Inclusion examinations, Aflibercept Injection [Eylea], SHAM injection, Examinations during study (every month)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inclusion examinationsOther
Pregnancy test, Visual acuity, ocular pressure, color retinophotography, OCT-SD (the Heidelberg SDOCT Spectralis, or the Cirrus HD-OCT, model 5000, Zeiss), OCT-angiography and fluorescein angiography and wide-field angiogram
Aflibercept Injection [Eylea]Drug
Intravitreal injection of aflibercept at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
SHAM injectionDrug
Intravitreal injection of SHAM at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
Examinations during study (every month)Other
visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6
| Study group | Role | What they receive |
|---|---|---|
| group aflibercept | Experimental | Not described Receives: Other: Inclusion examinations; Drug: Aflibercept Injection [Eylea]; Other: Examinations during study (every month) |
| control group | Placebo comparator | Not described Receives: Other: Inclusion examinations; Drug: SHAM injection; Other: Examinations during study (every month) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in central retinal thickness (CRT)
Measured: Between M0 and M6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start3 Jul 2019
- Primary completion26 Mar 2025
- Study completion26 Mar 2025
Why it stopped: very rare disease, many difficulties in recruiting patients, inclusion rate far too slow, making it impossible to meet the main objective within a reasonable timeframe. the sponsor therefore decided to stop the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular TelangiectasiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845049
- Sponsor's protocol ID
- CREUZOT PHRC N 2017
- Acronym
- TELeMAC
- Status last verified
- Jan 2026
- First submitted
- 15 Feb 2019
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
- ClinicalTrials.gov ID
- NCT03845049
- Acronym / sponsor ID
- TELeMAC / CREUZOT PHRC N 2017
- Conditions
- Macular Telangiectasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: very rare disease, many difficulties in recruiting patients, inclusion rate far too slow, making it impossible to meet the main objective within a reasonable timeframe. the sponsor therefore decided to stop the study.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Jul 2019 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 26 Mar 2025 (actual)
- First posted
- 19 Feb 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.
Idiopathic juxtafoveal telangiectasia type 1 is a rare unilateral disease that mostly affects men before 50 years of age. Mac Tel 1 are characterized by microvascular telangiectasia and increased tortuosity of the macular capillary network on the temporal part of the fovea that can be identified on fundus examination. It can be associated with peripheral vascular changes, similar to manifestations of Coats' disease. It can be complicated by macular edema due to leakage from microvascular ectasia. When associated with visual loss, macular edema can be treated with different strategies although there is no consensus about the best approach. Laser can be performed on leaky aneurysms with questionable long term efficacy and potential irreversible adverse effects. Recently, anti-VEGF agents have been put forward as particularly good candidates to treat this macular edema, as observed in vein occlusion or diabetic macular edema. Indeed, in limited case series, the first anti-VEGF agents (ranibizumab and bevacizumab) showed mitigated results. More recently, authors have reported some favorable results with aflibercept in patients refractory to other anti-VEGF agents. Indeed a recent study reported both good anatomical and functional results in macular edema due to Mac Tel 1 in a non-comparative study that included 8 patients and carried out a concomitant quantification of growth factors. As an explanation, the authors found that levels of placental growth factor (PlGF), which is targeted by aflibercept but not by other anti-VEGF agents, were decreased after treatment. Moreover, PlGF correlated with capillary plexus densities assessed by OCTA. The aim of this study is thus to assess the efficacy of a 6 months treatment by aflibercept compared to placebo in macular edema linked to Mac Tel 1 with a multicenter double-blind randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group aflibercept | Experimental | Other: Inclusion examinations, Drug: Aflibercept Injection [Eylea], Other: Examinations during study (every month) |
| control group | Placebo comparator | Other: Inclusion examinations, Drug: SHAM injection, Other: Examinations during study (every month) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patient who have given their written informed consent
- Patient major
- Patient with idiopathic macular telangiectasia type 1 identified at least 4 months previously, with or without peripheral exudative abnormalities
- Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCT images
- Patient with best-corrected ETDRS visual acuity between strictly24 and 79 letters
Key exclusion criteria (11 listed)
- Patient not affiliated to a national health insurance scheme
- Patient subject to a measure of legal protection (guardianship, tutorship)
- Patient subject to a court order
- Patient pregnant, parturient or nursing women (WOCBP)*
- Patient incapable of expressing consent
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 |
|---|---|---|
| Inclusion examinationsPregnancy test, Visual acuity, ocular pressure, color retinophotography, OCT-SD (the Heidelberg SDOCT Spectralis, or the Cirrus HD-OCT, model 5000, Zeiss), OCT-angiography and fluorescein angiography and wide-field angiogram | Other | control group, group aflibercept |
| Aflibercept Injection [Eylea]Intravitreal injection of aflibercept at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only. | Drug | group aflibercept |
| SHAM injectionIntravitreal injection of SHAM at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only. | Drug | control group |
| Examinations during study (every month)visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6 | Other | control group, group aflibercept |
Primary outcome
Change in central retinal thickness (CRT)
Time frame: Between M0 and M6
Results and safety
The study was stopped early (reason given: very rare disease, many difficulties in recruiting patients, inclusion rate far too slow, making it impossible to meet the main objective within a reasonable timeframe. the sponsor therefore decided to stop the study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inclusion examinations, Aflibercept Injection [Eylea] and Examinations during study (every month) in people with Macular Telangiectasia, run by Centre Hospitalier Universitaire Dijon 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 13 inclusion and 11 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 26 Jan 2026. 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.
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: very rare disease, many difficulties in recruiting patients, inclusion rate far too slow, making it impossible to meet the main objective within a reasonable timeframe. the sponsor therefore decided to stop the study.). 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?
Change in central retinal thickness (CRT) (time frame: Between M0 and M6). 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 26 Jan 2026.