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

An Eighteen-Month, Two-Arm, Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Adult Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion

ClinicalTrials.gov Identifier: NCT03810313

Novartis Reference Number: CRTH258C2302

Last Update: Dec 22, 2020

All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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).

Condition

Central Retinal Vein Occlusion

Phase

Phase 3

Overall status

Recruiting

Enrollment count

750 participants

Start date

Jul 03, 2019

Completion date

Oct 31, 2023

Gender

All

Age(s)

18 Years and older (Adult, Older Adult)

Interventions

Drug

Brolucizumab 6 mg

Solution for injection (intravitreal use)

Drug

Aflibercept 2 mg

Solution for injection (Intravitreal use)

Other

Sham injection

Empty sterile syringe without a needle administered as a sham injection for masking

Eligibility 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