To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR
NCT07230184 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-11-17
Summary
This study is planned to evaluate the efficacy and safety of combination therapy with B55R1 and B55R2 compared to B55R1 monotherapy in patients with non-proliferative diabetic retinopathy (NPDR).
Conditions
Interventions
- DRUG
-
B55R1 and B55R2
After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).
- DRUG
-
B55R1 and placebo for B55R2
After Randomization(Week 0), Participants will be administered with the drug, 2 times in a day, until end of trial(Week 24).
Sponsors & Collaborators
-
AJU Pharm Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 19 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-04-28
- Primary Completion
- 2023-08-14
- Completion
- 2024-08-16
Countries
- South Korea
Study Locations
More Related Trials
-
Safety and Efficacy of Low-Fluence PRP for PDR
NCT01737957 ·Status: TERMINATED ·Phase: NA
-
Conbercept vs Panretinal Photocoagulation for the Management of Proliferative Diabetic Retinopathy
NCT02911311 ·Status: UNKNOWN ·Phase: NA
-
Investigating the Structural and Functional Changes to the Retina Following PRP in Diabetic Retinopathy Patients
NCT02621580 ·Status: COMPLETED ·Phase: NA
-
Study to Assess the Efficacy and Safety of Monthly Octreotide Intramuscular Injections in Patients With Proliferative Diabetic Retinopathy After Lasercoagulation This Study is Not Being Conducted in the United States.
NCT00170742 ·Status: TERMINATED ·Phase: PHASE3
-
Biomarkers of Diabetic Retinopathy Progression
NCT01607190 ·Status: COMPLETED
-
PRP vs PRP+IVC for Severe nPDR
NCT03863535 ·Status: UNKNOWN ·Phase: NA
-
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
NCT05066230 ·Status: TERMINATED ·Phase: PHASE3
-
Panretinal Photo-stimulation in Proliferative Diabetic Retinopathy
NCT02309502 ·Status: WITHDRAWN ·Phase: NA
-
Effect of Argon Laser Panretinal Photocoagulation on Corneal Endothelial Cell Density .
NCT07157553 ·Status: NOT_YET_RECRUITING
-
Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
NCT01560715 ·Status: COMPLETED ·Phase: PHASE2
-
Laser (Selective Retina Therapy) and Drug Combined Intervention in Clinically Significant Diabetic Macular Edema
NCT03759860 ·Status: UNKNOWN ·Phase: PHASE4
-
Evaluation of RC28-E Injection in Diabetic Retinopathy
NCT04782128 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Comparison of Two Laser Therapy Methods for PDR
NCT01232179 ·Status: UNKNOWN ·Phase: PHASE2
-
Autologous Bone Marrow-Derived Stem Cells Transplantation For Retinitis Pigmentosa
NCT01068561 ·Status: COMPLETED ·Phase: PHASE1
-
Macular Perfusion Changes After Anti-VEGF Versus Targeted Retinal Photocoagulation in Proliferative Diabetic Retinopathy
NCT04674254 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluation of Macular Structural and Functional Function Following Extensive Retinal Laser Therapy in Patients With Proliferative Diabetic Retinopathy
NCT04436900 ·Status: COMPLETED ·Phase: NA
-
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
NCT00320814 ·Status: COMPLETED ·Phase: PHASE1
-
ETDRS PRP With IVR Versus Retinal Photocoagulation Targeted to Ischemic Retina With IVR for the Treatment of PDR
NCT03904056 ·Status: COMPLETED ·Phase: NA
-
A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients
NCT07199777 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Suprachoroidal Injection of CLS-TA Alone or With Aflibercept in Subjects With Diabetic Macular Edema
NCT02949024 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Study on Exosome Changes in Patients With Proliferative Diabetic Retinopathy
NCT06198543 ·Status: NOT_YET_RECRUITING
-
Proteomic Study of Plasma Exosomes in Patients With Diabetic Retinopathy
NCT06188013 ·Status: NOT_YET_RECRUITING
-
PASCAL Laser Versus ETDRS Laser Associated With Intravitreal Ranibizumab (IVR) Versus Only IVR for Proliferative Diabetic Retinopathy
NCT02005432 ·Status: UNKNOWN ·Phase: PHASE4
-
Conbercept Injection in Treatment of Severe Proliferative Diabetic Retinopathy
NCT02816710 ·Status: COMPLETED ·Phase: PHASE4
-
The Effect of Stem Cells and Stem Cell Exosomes on Visual Functions in Patients With Retinitis Pigmentosa
NCT05413148 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3