Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1

Comparative Multicenter Randomized Study of Aflibercept Versus Placebo in Macular Telangiectasia Type 1

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire Dijon

Source Centre Hospitalier Universitaire Dijon
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.

Overall Status Recruiting
Start Date July 3, 2019
Completion Date January 2022
Primary Completion Date January 2022
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in central retinal thickness (CRT) Between M0 and M6
Enrollment 46
Condition
Intervention

Intervention Type: Other

Intervention Name: Inclusion examinations

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: Aflibercept Injection [Eylea]

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.

Arm Group Label: group aflibercept

Intervention Type: Drug

Intervention Name: SHAM injection

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.

Arm Group Label: control group

Intervention Type: Other

Intervention Name: Examinations during study (every month)

Description: visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6

Eligibility

Criteria:

Inclusion Criteria:

- Patient who have given their written informed consent

- Patient major

- Patient with idiopathic macular telangiectasia type 1 identified at least 6 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 3 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 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).

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Catherine CREUZOT GARCHER

Phone: +33 3 80 29 51 73

Email: [email protected]

Location
Facility: Status: Contact: CHU dijon Bourgogne Catherine CREUZOT GARCHER, MD 3.80.29.51.73 +33 [email protected]
Location Countries

France

Verification Date

June 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: group aflibercept

Type: Experimental

Label: control group

Type: Placebo Comparator

Acronym TELeMAC
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Investigator)

Source: ClinicalTrials.gov