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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-511885-35-00
Enrollment
46
Registered
2024-05-28
Start date
2019-07-03
Completion date
2025-03-26
Last updated
2025-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

macular telangiectasia type 1

Brief summary

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

Detailed description

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

Interventions

Sponsors

Centre Hospitalier Universitaire De Dijon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in central retinal thickness between M0 and M6, measured by SD-OCT

Secondary

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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026