Clinical Trials Logo

Clinical Trial Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of KSI-301 administered at 12, 16 and 20 weeks intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with treatment-naïve neovascular (wet) age-related macular degeneration (nAMD).


Clinical Trial Description

This study is divided into a 3-week screening period, a 92-week treatment period, and a final 4-week follow-up period. At baseline patients will be randomized 1:1 into two treatment arms: KSI-301 5 mg and aflibercept 2 mg. At Week 52 patients on the aflibercept treatment arm will be re-randomized 1:1 into KSI-301 5 mg and aflibercept 2 mg. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04049266
Study type Interventional
Source Kodiak Sciences Inc
Contact
Status Terminated
Phase Phase 2/Phase 3
Start date September 30, 2019
Completion date April 26, 2022

See also
  Status Clinical Trial Phase
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Terminated NCT05038371 - Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
Completed NCT03278262 - The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting
Completed NCT04982484 - Reading Speed Improvements in Wet-AMD Patients After Ranibizumab Treatment
Completed NCT00590694 - Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments Phase 2/Phase 3
Completed NCT04516278 - A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders Phase 3
Completed NCT03844074 - A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) Phase 3
Recruiting NCT05637255 - A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD) Phase 2
Completed NCT04756310 - Study of Nutritional Supplementation in Patients With Unilateral Wet AMD N/A
Active, not recruiting NCT05112861 - A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders Phase 3
Enrolling by invitation NCT03999801 - Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy Phase 2
Terminated NCT03699618 - Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration
Completed NCT01666821 - A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population N/A
Completed NCT03022292 - The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy Phase 4
Completed NCT02944227 - Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration Phase 4
Terminated NCT03452527 - Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD) Phase 2
Completed NCT01243086 - OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab Phase 2
Completed NCT03823300 - A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE) Phase 3
Recruiting NCT04420923 - Optimizing the Treatment Strategy for Age-related Macular Degeneration N/A
Completed NCT03954626 - Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD Phase 3