Comparative multicenter randomized study of aflibercept versus placebo in macular telangiectasia type 1

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire De Dijon

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

3 Jul 2019 → 26 Mar 2025

Decision date (initial)

2024-05-28

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

External identifiers

EU CT number

2024-511885-35-00

EudraCT number

2018-004327-36

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

To compare the evolution of central retinal thickness between M0 and M6 in patients with macular edema due to Mac Tel 1 treated with aflibercept versus placebo.

Secondary objectives 5

1. To compare ETDRS visual gain between M0 and M6 with aflibercept versus placebo
2. To compare the evolution of retinal volume between M0 and M6
3. To compare the evolution between M0 and M6 of perifoveolar capillaries in the deep and superficial plexuses
4. To compare the evolution between M0 and M6 of the number of abnormal microvascular lesions in the deep and superficial plexuses
5. To assess the safety of aflibercept by monitoring ocular adverse events and systemic adverse events

Conditions and MedDRA coding

macular telangiectasia type 1

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patient who have given their written informed consent
2. Patient major
3. Patient with idiopathic macular telangiectasia type 1 identified at least 4 months previously, with or without peripheral exudative abnormalities
4. Patient with macular edema more than 320 μm confirmed by a blind review of SD-OCT images
5. Patient with best-corrected ETDRS visual acuity between strictly 24 and 79 letters
6. 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
7. 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
8. 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 11

1. Patient not affiliated to a national health insurance scheme
2. Patient subject to a measure of legal protection (guardianship, tutorship)
3. Patient subject to a court order
4. Patient pregnant, parturient or nursing women (WOCBP)
5. Patient incapable of expressing consent
6. 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…)
7. Patient presenting any cardiovascular event within 6 months before inclusion
8. Poor media clarity, which can prevent adequate fundus imaging
9. Patient with hypersensitivity to the active substance (aflibercept) or to any of the excipients of EYLEA®
10. Patient with active or suspected ocular or periocular infection or severe active intraocular inflammation
11. 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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in central retinal thickness between M0 and M6, measured by SD-OCT

Secondary endpoints 5

1. Evolution between M0 and M6 of visual acuity measured on the ETDRS scale
2. Evolution between M0 and M6 of retinal volume measured by SD-OCT
3. Evolution between M0 and M6 of perifoveolar capillary density in the superficial and deep capillary plexus measured by OCTA
4. Evolution between M0 and M6 of number of abnormal microvascular lesions in the superficial and deep capillary plexus measured by OCTA
5. Ocular safety (sustainable elevation of ocular pressure, cataract, intraocular inflammation, infectious endophthalmitis, retinal detachment, retinal tear, vitreous or subretinal hemorrhage

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire De Dijon

Sponsor organisation

Centre Hospitalier Universitaire De Dijon

Address

1 Boulevard Jeanne D Arc, Bp 77908 Bp 77908

City

Dijon

Postcode

21000

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de Projet

Public contact point

Organisation

Centre Hospitalier Universitaire De Dijon

Contact name

Chef de Projet

Locations

1 EU/EEA country · 12 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 4 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

3 submissions — initial application plus substantial / non-substantial modifications