Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1 (TELeMAC)
Primary Purpose
Macular Telangiectasia
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Inclusion examinations
Aflibercept Injection [Eylea]
SHAM injection
Examinations during study (every month)
Sponsored by
About this trial
This is an interventional treatment trial for Macular Telangiectasia
Eligibility Criteria
Inclusion Criteria:
- 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 with a contraindication for laser photocoagulation or with persistence of macular edema after treatment with intravitreal bevacizumab, ranibizumab and/or laser photocoagulation administered 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
Exclusion Criteria:
- 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…)
- Patient treated with aflibercept in the last 4 months before inclusion
- Patient presenting any cardiovascular eventwithin 6 months before inclusion
- Poor media clarity, which can prevent adequate fundus imaging
- Patient having prior focal photocoagulation within the previous 4 months
- 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).
Sites / Locations
- CHU dijon BourgogneRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
group aflibercept
control group
Arm Description
Outcomes
Primary Outcome Measures
Change in central retinal thickness (CRT)
Secondary Outcome Measures
Full Information
NCT ID
NCT03845049
First Posted
February 15, 2019
Last Updated
February 27, 2023
Sponsor
Centre Hospitalier Universitaire Dijon
1. Study Identification
Unique Protocol Identification Number
NCT03845049
Brief Title
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Acronym
TELeMAC
Official Title
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 3, 2019 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Telangiectasia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
46 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group aflibercept
Arm Type
Experimental
Arm Title
control group
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Inclusion examinations
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection [Eylea]
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
SHAM injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Examinations during study (every month)
Intervention Description
visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6
Primary Outcome Measure Information:
Title
Change in central retinal thickness (CRT)
Time Frame
Between M0 and M6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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
Exclusion Criteria:
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…)
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Catherine CREUZOT GARCHER
Phone
+33 3 80 29 51 73
Email
catherine.creuzot-garcher@chu-dijon.fr
Facility Information:
Facility Name
CHU dijon Bourgogne
City
Dijon
ZIP/Postal Code
21000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine CREUZOT GARCHER, MD
Phone
3.80.29.51.73
Ext
+33
Email
catherine.creuzot-garcher@chu-dijon.fr
12. IPD Sharing Statement
Learn more about this trial
Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1
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