Overview

Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

Status:
Completed
Trial end date:
2021-07-26
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Aflibercept
Criteria
Inclusion Criteria:

- Signed informed consent must be obtained prior to participation in the study.

- Patients with visual impairment due to ME secondary to CRVO diagnosed < 6 months prior
to screening.

- BCVA score between 78 and 23 letters, inclusive, using ETDRS visual acuity testing
charts (approximate Snellen equivalent of 20/32 to 20/320) at both screening and
baseline visits.

Exclusion criteria

- Concomitant conditions or ocular disorders in the study eye at screening or baseline
which could, in the opinion of the investigator, prevent response to study treatment
or may confound interpretation of study results, compromise visual acuity or require
medical or surgical intervention during the first 12-month study period (e.g.
structural damage of the fovea, vitreous hemorrhage, retinal vascular occlusion other
than CRVO, retinal detachment, macular hole, or choroidal neovascularization of any
cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular
edema).

- Any active intraocular or periocular infection or active intraocular inflammation
(e.g. infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious
blepharitis, uveitis) in study eye at screening or baseline

- Uncontrolled glaucoma in the study eye defined as intraocular pressure (IOP) > 25 mmHg
on medication, or according to investigator's judgment, at screening or baseline

- Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA <
20/200 at screening (except when due to conditions whose surgery may improve VA, e.g.
cataract)

- Previous treatment with any anti-VEGF therapy or investigational drugs in the study
eye at any time prior to baseline

- Previous use of intraocular or periocular steroids in study eye at any time prior to
baseline

- Macular laser photocoagulation (focal/grid) in the study eye at any time prior to
baseline and peripheral laser photocoagulation in the study eye within 3 months prior
to the baseline

- Intraocular surgery in the study eye during the 3-month period prior to baseline

- Vitreoretinal surgery in the study eye at any time prior to baseline

- Aphakia with the absence of posterior capsule in the study eye