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

PHASE3RecruitingINTERVENTIONAL
Enrollment

46

Participants

Timeline

Start Date

July 3, 2019

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

Conditions
Macular Telangiectasia
Interventions
OTHER

Inclusion examinations

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

DRUG

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

SHAM injection

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.

OTHER

Examinations during study (every month)

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

Trial Locations (1)

21000

RECRUITING

CHU dijon Bourgogne, Dijon

All Listed Sponsors
lead

Centre Hospitalier Universitaire Dijon

OTHER