Study assessing the efficacy and safety of Brolucizumab versus Aflibercept in patients with impaired vision due to diabetic macular oedema

Phase 1

Conditions: Diabetic Macular Edema
MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2019-001004-37-HU

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 495

Inclusion Criteria

1- Signed informed consent must be obtained prior to participation in the study
2- Patients to be 18 years of age or over at baseline
3- Patients with type 1 or type 2 diabetes mellitus and HbA1c = 12% at screening
3- Patients with visual impairment due to DME with
-BCVA score between 73 and 23 letters, inclusive, using ETDRS visual acuity testing charts at a testing distance of 4 meters (approximate Snellen equivalent of 20/40 to 20/320) at both screening and baseline.
-DME involving the center of the macula, with CSFT = 320 µm on SD-OCT at screening
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 371
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124

Exclusion Criteria

Ocular conditions
-High-risk proliferative diabetic retinopathy (PDR) in the study eye as per investigator assessment at both screening and baseline
-Concomitant conditions or ocular disorders in the study eye at screening or baseline which may, in the opinion of the investigator, confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 12-month study period (eg, structural
damage of the fovea, vitreous hemorrhage, retinal detachment, vitreomacular traction, macular hole, retinal vein/arterial occlusion,
neovascularization of iris or choroidal neovascularization (CNV) of any cause).
-Any active intraocular or periocular infection or active intraocular inflammation in the either 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, eg, cataract)
Ocular treatments
-Use of anti-VEGF therapies, intraocular surgery or laser photocoagulation (macular or panretinal) in the study eye during the 3-month period prior to
baseline
-Use of intraocular or periocular corticosteroids including dexamethasone intravitreal implant (Ozurdex) in the study eye during the 6-month period
prior to baseline, and use of fluocinolone acetonide intravitreal (IVT) implant (Iluvien) at any time prior to baseline
-Prior investigational drugs in either eye, vitreoretinal surgery in the study eye at any time prior to baseline

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate that brolucizumab is non-inferior to aflibercept with respect to the change in visual acuity from baseline up to week 52;Secondary Objective: 1. To assess the effect of brolucizumab compared with aflibercept with respect to anatomical outcomes<br>2. To assess the effect of brolucizumab compared with aflibercept with respect to visual acuity<br>3. To assess the effect of brolucizumab relative to aflibercept on the status of Diabetic Retinopathy<br>4. To assess the safety and tolerability of brolucizumab compared to aflibercept<br>5. To assess the immunogenicity of brolucizumab;Primary end point(s): Change from baseline in BCVA at Week 52;Timepoint(s) of evaluation of this end point: Baseline and Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1.<br>-Change from baseline in CSFT at each post-baseline visit<br>-Proportion of study eyes with fluid-free macula at each post-baseline visit<br>-Proportion of study eyes with absence of DME (CSFT < 280 µm) at each post-baseline visit<br>-Time to first fluid-free macula<br>-Time to first absence of DME (CSFT < 280 µm)<br>2.<br>-Change from baseline in BCVA at each post-baseline visit<br>-Proportion of study eyes with gain in BCVA of 5/10/15 letters or more at each post-baseline visit compared to baseline<br>3.<br>-Change from baseline in ETDRS Diabetic Retinopathy Severity Scale (DRSS) score at Week 12, Week 24 and Week 52<br>4.<br>-Incidence of ocular and non-ocular Adverse Events (AEs)<br>5.<br>-Anti-drug antibody (ADA) measurement<br>;Timepoint(s) of evaluation of this end point: Baseline, Weeks 12, 24, 52

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