Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impa… (NCT03810313) | Clinical Trial Compass
TerminatedPhase 3
Assessing the Efficacy and Safety of Brolucizumab Versus Aflibercept in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
Stopped: Study was terminated by sponsor due to increased incidences of adverse events of special interest (intraocular inflammation including retinal vasculitis, and retinal vascular occlusion), in patients dosed every 4 weeks beyond 3 initial doses.
United States493 participantsStarted 2019-07-03
Plain-language summary
The purpose of this study was to evaluate the efficacy and safety of brolucizumab in treatment of patients with macular edema (ME) secondary to central retinal vein occlusion (CRVO).
Who can participate
Age range18 Years
SexALL
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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 scr…
What they're measuring
1
Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24