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A 96-week, two-arm, randomized, single-masked, multi-center, phase III study assessing the efficacy and safety of brolucizumab 6 mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy (CONDOR)

PHRR210216-003336

CRTH258D2301

2020-CT0583

A 96-week, two-arm, randomized, single-masked, multi-center, phase III study assessing the efficacy and safety of brolucizumab 6 mg compared to panretinal photocoagulation laser in patients with proliferative diabetic retinopathy (CONDOR)

The study is a 96-week, two-arm, randomized, single-masked, multi-center, active-controlled, non-inferiority study in patients with proliferative diabetic retinopathy (PDR).

Subjects who meet all the inclusion and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms:

  • Brolucizumab 6 mg: 3 x q6w loading then q12w maintenance through Week 90, with the option from Week 48 onwards to extend the treatment interval by 6 weeks at a time up to 24 weeks.
  • Panretinal Photocoagulation (PRP): initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed up to Week 90.

Start Date Duration in Months Target Completion Date Actual Completion Date
2021-04-15 22 2023-02-15 0000-00-00

Pending

Awaiting SIV

Institution Classification Region LTO #
Novartis Healthcare Philippines, Inc. Private Business NCR LTO-3000006283930
Institution Region
Novartis Pharma Services AG Switzerland
Name E-Mail Institution and Institution Address
Anna Liza Calingasin anna_liza.calingasin@novartis.com Novartis Healthcare Philippines, Inc., 5th Floor, Ayala North Exchange Tower 1, Ayala Avenue corner Amorsolo Street, Legazpi Village, Makati City 1229
Name E-Mail Institution and Institution Address
Ivy Emily Peneyro-Vergara, MD ivy_emily.peneyrovergara@novartis.com Novartis Healthcare Philippines, Inc., 5th Floor, Ayala North Exchange Tower 1, Ayala Avenue corner Amorsolo Street, Legazpi Village, Makati City 1229
Name Expertise Affiliation
Amadeo Veloso, Jr., MD Ophthalmology Asian Eye Institute
Harvey Uy, MD Ophthalmology Peregrine Eye and Laser Institute
Sherman Valero, MD Ophthalmology The Medical City
Project Location Institutional Ethics Review Board
Asian Eye Institute Asian Eye Institute Ethics Review Committee
Peregrine Eye and Laser Institute Peregrine Eye and Laser Institute Institutional Review Board
The Medical City The Medical City - Institutional Review Board

Proliferative Diabetic Retinopathy

Primary objective(s)

Endpoint(s) for primary objective(s)

To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54

Change from Baseline in Best Corrected Visual Acuity (BCVA) at Week 54

Secondary objective(s)

Endpoint(s) for secondary objective(s)

To demonstrate that brolucizumab is superior to PRP in reducing diabetic retinopathy severity at Week 54

Proportion of subjects with no Proliferative Diabetic Retinopathy (PDR) at Week 54 

To demonstrate that brolucizumab is superior to PRP in preventing the development of center-involved DME up to Week 54

Proportion of subjects with center-involved Diabetic Macular Edema (DME) up to Week 54

To compare the effect of brolucizumab relative to PRP with respect to visual acuity

Area under the curve in change from Baseline in Best Corrected Visual Acuity (BCVA) up to Week 54 and Week 96

To compare the effect of brolucizumab relative to PRP on diabetic retinopathy status

Change from Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score at Week 54 and Week 96

Proportion of subjects with no PDR at Week 96

To compare the effect of brolucizumab relative to PRP on ocular complications

Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96

Proportion of subjects with center-involved Diabetic Macular Edema (DME) up to Week 96

To assess the safety and tolerability of brolucizumab relative to PRP

·Incidence of ocular and non-ocular adverse events (AE) up to Week 54 and Week 96

Recruiting

  • Argentina
  • Australia
  • Brazil
  • Canada
  • Chile
  • China
  • India
  • Japan
  • Mexico
  • Philippines
  • Russia
  • Saudi Arabia
  • South Korea
  • Taiwan
  • Turkey
  • United States

Clinical Trial

CRTH258D2301

20201120115234

2021-01-19

0000-00-00

18

Unspecified

Unspecified

2021-04-15

Key Inclusion criteria

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

·       Patients ≥ 18 years of age at Screening.

·       Participant cooperation sufficient for adequate fundus photographs and retinal images.

·       Patients diagnosed with diabetes mellitus (DM) type 1 or 2, and HbA1c ≤  12% at Screening.

·       Any medication administered for the management of diabetes should be stable within 3 months prior to randomization and is expected to remain stable during the course of the study, as medically acceptable. 

·       PDR in the study eye as assessed by the investigator using standard or wide-field color fundus photography (CFP) and fluorescein angiography (FA), with no evidence of previous PRP, and that requires treatment with either anti-Vascular Endothelial Growth Factor (VEGF) agent or PRP in the opinion of the investigator.

·       BCVA ≥ 34 ETDRS letters (Snellen equivalent 20/200) in the study eye at Screening and Baseline.

Key Exclusion criteria

·       Concomitant conditions or ocular disorders in the study eye at Screening or Baseline as well as planned medical/surgical intervention during the first 54-week study period that could compromise functional or structural response to study treatment, in the opinion of the investigator

·       Presence of center-involved DME in the study eye at Screening or Baseline, as assessed by the investigator.

·       Other ocular conditions in the study eye:

·       Any active intraocular or periocular infection or active intraocular inflammation at Screening or Baseline.

·       Uncontrolled glaucoma in defined as intraocular pressure (IOP) > 25 mmHg despite treatment with IOP lowering medication, or according to investigator’s judgment, at Screening or Baseline.

·       Iris or anterior chamber angle neovascularization, or neovascular glaucoma.

·       Moderate or dense pre-retinal or vitreous hemorrhage that prevents clear visualization of the macular and / or optic disc or prevents PRP treatment at Baseline.

·       Significant fibrovascular vitreoretinal proliferation or tractional retinal detachment.

·       Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 20/200 at screening (except when due to conditions for which treatment or surgery may improve VA).

·       Ocular treatments in the study eye:

·       PRP any time prior to Baseline.

·       Intravitreal anti-VEGF treatment within six months prior to Baseline.

·       Vitreoretinal surgery at any time prior to Baseline or anticipated need for vitreoretinal surgery within the next 12 months.

·       Laser treatment of the macula within 3 months prior to Baseline. 

·       Treatment with fluocinolone acetonide intravitreal implant at any time prior to Baseline. Other intraocular or periocular corticosteroid injection within 6 months prior to Baseline.

·       Intraocular surgery within 3 months prior to Baseline or anticipated need for cataract extraction within the next 12 months.

·       Systemic conditions or treatments: stroke or myocardial infarction during the 6-month period prior to baseline, end stage renal disease requiring dialysis or renal transplant, systemic anti-VEGF therapy at any time.

Interventional

RTH258 (Brolucizumab)

Investigational Drug

Pharmaceutical Dosage Form

Route of Administration

Supply Type

Brolucizumab 6 mg (RTH258 6 mg/ 0.05 mL)

Solution for injection

Intravitreal use

Glass vial

Date Amendment Classification Reason
2021-03-22 Amendments related to the trial arrangements Increase in patient number from 16 to 18
2021-09-23 Amendments related to the protocol Informed consent

Randomized

Single Blind

This study will be single-masked with subjects randomized using IRT to be treated with brolucizumab 6 mg or PRP. Because of the difference in the mode of administration of brolucizumab (the investigational drug) and PRP (the comparator treatment), the duration of the two procedures, and the visible scars resulting from PRP on CFP, subjects as well as evaluating and treating investigators cannot be masked to treatment. To ensure single masking, the site personnel who will perform the BCVA and peripheral visual field assessments will be masked to the identity of the treatment from the time of randomization until the final database lock. The masked site personnel will be independent from the unmasked site staff who will perform the clinical evaluation and administer the study treatment. Once the designated roles are determined, the unmasked investigator/site personnel must not be switched at any time after randomization to masked role.  The source documentation specific to BCVA, perimetry, and retinal imaging logs will be separately filled and provided to unmasked staff with no communication about treatment of the subject. The masked personnel will not have access to the other source documentation and the EDC system.  Subjects, field monitors, and unmasked site staff will be asked not to communicate any information related to the study treatment to the masked site personnel, as documented in the patient informed consent form and in any other study form describing staff responsibilities. Masking to the original treatment assignment will be maintained for the masked personnel at the site level until the end of the study. Additionally, an independent review of images collected at pre-defined time-points for subjects enrolled in the study will be performed at a CRC. Independent readers of CFP images will be masked to the study treatment, the study visit number, and the investigator's disease activity assessment.

Parallel

The purpose of this study is to evaluate the efficacy and safety of brolucizumab compared to PRP in subjects with PDR.

Phase III

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