A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema
NCT05489718 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2023-10-27
Summary
This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME
Conditions
Interventions
- BIOLOGICAL
-
IBI324
Dose 2 IBI324 of multiple IVT injection
- BIOLOGICAL
-
IBI324
Dose 2 IBI324 of single IVT injection
- BIOLOGICAL
-
IBI324
Dose 1 IBI324 of single IVT injection
- BIOLOGICAL
-
IBI324
Dose 3 IBI324 of single IVT injection
- BIOLOGICAL
-
IBI324
Dose 3 IBI324 of multiple IVT injection
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2023-06-05
- Completion
- 2023-06-05
Countries
- China
Study Locations
More Related Trials
-
Pilot Study for the Evaluation of Intravitreal Infliximab in the Treatment of Diabetic Macular Edema
NCT00959725 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of 9MW0813 in Subjects With Diabetic Macular Edema
NCT05324774 ·Status: UNKNOWN ·Phase: PHASE3
-
Safety and Efficacy Study of Conbercept in Diabetic Macular Edema (DME) (Sailing)
NCT02194634 ·Status: UNKNOWN ·Phase: PHASE3
-
A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)
NCT03511898 ·Status: COMPLETED ·Phase: PHASE1
-
Gene Therapy for DME
NCT06492876 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Diabetic Macular Edema: Relevance of Staging Progression on Therapeutic Outcome
NCT05080803 ·Status: COMPLETED
-
Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
NCT01702441 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
NCT02732951 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema
NCT06422507 ·Status: COMPLETED ·Phase: PHASE3
-
A Clinical Study Evaluating the Safety, Tolerability and Initial Efficacy of SKG0106 Intravitreal Injection in Diabetic Macular Edema (DME) Patients
NCT06237777 ·Status: RECRUITING ·Phase: PHASE1
-
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
NCT00490815 ·Status: COMPLETED ·Phase: PHASE3
-
The Study of Drug 601 in Patients With Diabetic Macular Edema (DME)
NCT04151407 ·Status: UNKNOWN ·Phase: PHASE1
-
Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema
NCT05271539 ·Status: COMPLETED ·Phase: PHASE3
-
A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients
NCT07199777 ·Status: NOT_YET_RECRUITING ·Phase: PHASE2
-
Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan
NCT04288232 ·Status: COMPLETED ·Phase: PHASE3
-
Fluocinolone Acetonide Implant Compared to Sham Injection in Patients With Diabetic Macular Edema
NCT00344968 ·Status: COMPLETED ·Phase: PHASE3
-
Diabetic Macular Edema (DME) Treatment With Ranibizumab and Dexamethasone or Ranibizumab Only.
NCT04601675 ·Status: UNKNOWN ·Phase: NA
-
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion
NCT00308477 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Early Anatomical, Physiological, and Clinical Changes in Diabetic Macular Edema After Intravitreal Aflibercept Injection
NCT03453281 ·Status: COMPLETED ·Phase: PHASE4
-
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
NCT06708260 ·Status: RECRUITING ·Phase: PHASE2
-
New Concepts in Diabetic Macular Edema (DME)
NCT04186702 ·Status: COMPLETED ·Phase: NA
-
Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)
NCT01324869 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Intravitreous Bevacizumab and Standard Metabolic Control for Diabetic Macular Edema - A Contrast Sensitivity Study
NCT02308644 ·Status: COMPLETED ·Phase: PHASE3
-
Intravitreal Diclofenac Versus Intravitreal Ranibizumab for the Treatment of Diabetic Macular Edema.
NCT03458923 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy Analysis of Anti-VEGF Drugs Combined With Micropulse Laser in the Treatment of Diabetic Macular Edema
NCT05759884 ·Status: UNKNOWN ·Phase: NA