Trial to Evaluate the Safety and Tolerability of Repeated Intravitreal Injection of IBI302 in Neovascular AMD Patients
NCT04370379 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2021-11-11
Summary
This study is designed for multi-center, open-label, randomized, dose escalation phase I trial to evaluate the safety and tolerability of a multiple dose intravitreal injection of IBI302 in neovascular AMD patients.
Conditions
- Neovascular Age-related Macular Degeneration
Interventions
- DRUG
-
IBI302 (the first dose level)
q4week (3 injections) followed by PRN dosing
- DRUG
-
IBI302 (the second dose level)
q4week (3 injections) followed by PRN dosing
- DRUG
-
2mg, q4week (3 injections) followed by q8week
Sponsors & Collaborators
-
Innovent Biologics (Suzhou) Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-05-28
- Primary Completion
- 2021-04-30
- Completion
- 2021-05-08
Countries
- China
Study Locations
More Related Trials
-
A Study of Longer Interval of IVT IBI302 in Subjects With nAMD
NCT05403749 ·Status: COMPLETED ·Phase: PHASE2
-
A Dose Escalation Study of IBI333 in Subjects With Neovascular Age-related Macular Degeneration
NCT05639530 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Efficacy Study of IVB103 Injection in Subjects With Neovascular (Wet) Agerelated Macular Degeneration (nAMD).
NCT06737354 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE1
-
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
NCT04126317 ·Status: COMPLETED ·Phase: PHASE2
-
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration
NCT02121522 ·Status: COMPLETED ·Phase: PHASE2
-
Safety of BBC1501 Intravitreal Injection in Patients With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05803785 ·Status: RECRUITING ·Phase: PHASE1
-
Safety and Tolerability of Oral CM082 in Patients With wAMD
NCT03710863 ·Status: UNKNOWN ·Phase: PHASE2
-
A Study of Single Intravitreal Injection HB002.1M in Subjects With Neovascular Age-Related Macular Degeneration
NCT03387566 ·Status: COMPLETED ·Phase: PHASE1
-
Aflibercept Injection Into the Vitreous Body of the Eye: Study to Learn More About Patient Relevant Outcomes, Real World Treatment Patterns and How Well the Treatment Works for Patients Suffering From Abnormal Growth of New Blood Vessels Under the Retina.
NCT03714308 ·Status: COMPLETED
-
A Study to Evaluate the Efficacy and Safety of MW02 in the Treatment of nAMD
NCT05297292 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
NCT01896284 ·Status: COMPLETED ·Phase: PHASE4
-
Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
NCT01997164 ·Status: COMPLETED ·Phase: PHASE1
-
VEGF Trap-Eye: Investigation of Efficacy and Safety in Chinese Subjects With Wet AMD (Age-Related Macular Degeneration)
NCT01482910 ·Status: COMPLETED ·Phase: PHASE3
-
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Neovascular (Wet) Age-related Macular Degeneration (wAMD)
NCT04964089 ·Status: COMPLETED ·Phase: PHASE3
-
Study Evaluating the Safety, Pharmacokinetics and Pharmacodynamics of OPT-302 With or Without Lucentis™ in Patients With Wet AMD
NCT02543229 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Test Different Doses of BI 836880 in Patients With an Eye Disease Called Wet Age-related Macular Degeneration (wAMD)
NCT03861234 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)
NCT06888492 ·Status: NOT_YET_RECRUITING ·Phase: EARLY_PHASE1
-
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
NCT06491914 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD
NCT04884399 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn How Well Aflibercept Injected Into the Eye Works and How Safe it is When Given in Customized Treatment Intervals in Patients With an Eye Disease Called Neovascular Age-related Macular Degeneration After Start of Treatment
NCT05473715 ·Status: TERMINATED ·Phase: PHASE4
-
Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)
NCT00320788 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of EXG102-031 in Participants With wAMD
NCT06183814 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
To Evaluate The Role of Intravitreal Aflibercept Injection (2.0 mg) in the Management of Previously Treated Patients With Exudative AMD
NCT01495221 ·Status: COMPLETED ·Phase: PHASE4
-
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
NCT01941082 ·Status: COMPLETED ·Phase: PHASE1
-
Trial to Evaluate the Safety and Efficacy of EB-203 in Patients With Neovascular Age-related Macular Degeneration
NCT06487039 ·Status: RECRUITING ·Phase: PHASE2