Clinical Trials List
Protocol NumberCRTH258D2301
Completed
2020-10-30 - 2025-07-28
Phase III
Recruiting2
ICD-10E11.351
Type 2 diabetes mellitus with proliferative diabetic retinopathy with macular edema
ICD-10E11.359
Type 2 diabetes mellitus with proliferative diabetic retinopathy without macular edema
ICD-9362.02
Proliferative diabetic retinopathy
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)
-
Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
-
Sponsor
Novartis Pharmaceuticals
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
patients with proliferative diabetic
Objectives
To demonstrate that brolucizumab is non-inferior to PRP with respect to the change from Baseline in visual acuity at Week 54 by assessing the change from Baseline in best corrected visual acuity (BCVA) at Week 54
Test Drug
RTH258 (Brolucizumab)
Active Ingredient
RTH258 (Brolucizumab)
Dosage Form
Solution for injection
Solution for injection in prefilled syringe
Solution for injection in prefilled syringe
Dosage
6 mg
6 mg
6 mg
Endpoints
The objective related to first key secondary endpoint is to demonstrate superiority of brolucizumab versus PRP with respect to increasing the proportion of subjects with no PDR at Week 54. It will be tested via Cochran-Mantel-Haenszel (CMH) test at a one-sided significance level of 0.025, after non-inferiority for the primary endpoint is established.
The objective related to the other key secondary endpoint is to demonstrate superiority of brolucizumab versus PRP with respect to reducing the proportion of subjects with center-involved DME up to Week 54. It will be tested via CMH test at a one-sided significance level of 0.025, after superiority is established for both primary endpoint and first key secondary endpoint.
The objective related to the other key secondary endpoint is to demonstrate superiority of brolucizumab versus PRP with respect to reducing the proportion of subjects with center-involved DME up to Week 54. It will be tested via CMH test at a one-sided significance level of 0.025, after superiority is established for both primary endpoint and first key secondary endpoint.
Inclution 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.
• 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.
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.
• 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.
The Estimated Number of Participants
-
Taiwan
11 participants
-
Global
706 participants
