Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
NCT07516132 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 850
Last updated 2026-07-01
Summary
Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study
Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
Interventions
- DRUG
-
Intravitreal Injection of OTX-TKI
Sponsors & Collaborators
-
Fortrea
collaborator INDUSTRY -
Duke Reading Center
collaborator UNKNOWN -
Ocular Therapeutix, Inc.
lead INDUSTRY
Principal Investigators
-
Dilsher Dhoot, MD · California Retina Consultants (CRC)-Bakersfield
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-27
- Primary Completion
- 2030-08-01
- Completion
- 2030-08-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration
NCT04746963 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
NCT05859776 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of Multiple Intravitreal Injection TK001 in Patients With Neovascular Age-related Macular Degeneration
NCT03021785 ·Status: UNKNOWN ·Phase: PHASE1
-
OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)
NCT04757610 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Tolerability of KH631 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)
NCT05672121 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
Clinical Study to Evaluate the Handling and Safety of AVT06 PFS in Subjects With Chorioretinal Vascular Disease
NCT05986786 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Tolerability Study of AAV2-sFLT01 in Patients With Neovascular Age-Related Macular Degeneration (AMD)
NCT01024998 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II/III Study of Anti-VEGF in Neovascular AMD
NCT00021736 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-Related Macular Degeneration
NCT06856577 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
A Clinical Study Evaluating the Safety and Efficacy of SKG0106 in Patients With Neovascular Age-related Macular Degeneration (nAMD)
NCT06213038 ·Status: RECRUITING ·Phase: PHASE1
-
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
NCT05210803 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2
-
A Long-term Follow up Study of EXG102-031 in Participants With wAMD
NCT06859515 ·Status: RECRUITING
-
Evaluating RXI-109 to Reduce the Progression of Subretinal Fibrosis in Subjects With NVAMD
NCT02599064 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
A Follow-up Study to Evaluate the Safety of RetinoStat® in Patients With Age-Related Macular Degeneration
NCT01678872 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Efficacy and Safety Study of Ixoberogene Soroparvovec (Ixo-vec) in Participants With Neovascular Age-related Macular Degeneration (AQUARIUS)
NCT07482176 ·Status: RECRUITING ·Phase: PHASE3
-
A Safety and Efficacy Study of Brimonidine Intravitreal Implant in Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT02087085 ·Status: TERMINATED ·Phase: PHASE2
-
Efficacy and Safety of LX102 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD) (STELLAR)
NCT07317934 ·Status: RECRUITING ·Phase: PHASE3
-
An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
NCT07392255 ·Status: RECRUITING ·Phase: PHASE1/PHASE2
-
A Study of an Encapsulated Cell Technology (ECT) Implant for Patients With Atrophic Macular Degeneration
NCT00447954 ·Status: COMPLETED ·Phase: PHASE2
-
Intravitreal LFG316 in Patients With Advanced Age-related Macular Degeneration
NCT01255462 ·Status: COMPLETED ·Phase: PHASE1
-
Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
NCT04704921 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2/PHASE3
-
A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravitreal Injections of RO7303359 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT04615325 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa
NCT00447980 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1/2 Study of AGN-241622 in Healthy Participants and Participants With Presbyopia
NCT04403763 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy
NCT03999801 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2