A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO) (BEACON)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT04592419 |
|
Recruitment Status :
Completed
First Posted : October 19, 2020
Last Update Posted : February 9, 2023
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Macular Edema Retinal Vein Occlusion | Drug: KSI-301 Drug: Aflibercept Other: Sham Procedure | Phase 3 |
This is a Phase 3, prospective, randomized, double-masked, two-arm, multi-center non-inferiority study evaluating the efficacy and safety of repeated intravitreal dosing of KSI-301 5 mg in participants with visual impairment due to treatment-naïve macular edema secondary to RVO (either branch or central type).
The primary endpoint will be assessed at Week 24; additional secondary endpoints for efficacy will be assessed at Week 24 and Week 48.
This includes an optional open-label, two-arm, double-masked Extension Phase in which participants completing the primary BEACON study are eligible to participate. All participants who enroll into the Extension Phase will be treated with KSI-301 5 mg. The Extension Phase will have the final study assessment at Week 72 for efficacy endpoints and a final safety follow-up at Week 76.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 568 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Participants will be randomized 1:1 into one of two treatment arms: KSI-301 or aflibercept. Participants in the Extension Phase will be treated with KSI-301. |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | For masking purposes, sham injections will be administered at every monthly visit if an active treatment is not administered. To preserve masking, two investigators are required for this study. The masked Investigator will be responsible for the examinations and safety assessments. The unmasked Investigator will perform the injections and post-treatment assessments. |
| Primary Purpose: | Treatment |
| Official Title: | A Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center, Two-arm, Phase 3 Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept in Participants With Visual Impairment Due to Treatment-naïve Macular Edema Secondary to Retinal Vein Occlusion (RVO) |
| Actual Study Start Date : | September 25, 2020 |
| Actual Primary Completion Date : | June 20, 2022 |
| Actual Study Completion Date : | January 19, 2023 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: KSI-301 (Arm A)
Intravitreal injection of KSI-301 (5 mg) at Day 1, Week 4, and once every 8 weeks through Week 20 followed by an individualized dosing regimen of Intravitreal injection of KSI-301 (5 mg) from Week 24 to Week 44. In the Extension Phase, participants randomized to KSI-301 (5 mg) in the Primary Study will continue to receive KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
Drug: KSI-301
Intravitreal Injection Other: Sham Procedure The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
|
Active Comparator: Aflibercept (Arm B)
Intravitreal injection of aflibercept (2 mg) once every 4 through Week 20 followed by an individualized dosing regimen of Intravitreal injection of Aflibercept (2 mg) once every 4 weeks from Week 24 to Week 44. In the Extension Phase, participants randomized to aflibercept in the Primary Study will cross over to treatment with KSI-301 (5 mg). They will receive their first dose of KSI-301 (5 mg) at Week 48 and will receive additional treatment with KSI-301 (5 mg) based on protocol-defined disease activity criteria. |
Drug: Aflibercept
Intravitreal Injection
Other Name: Eylea Other: Sham Procedure The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking. |
- Non-inferiority of KSI-301 to Aflibercept measured by changes in BCVA. [ Time Frame: Day 1 to Week 24 ]Demonstrate that KSI-301 5 mg administered every 8 weeks after 2 monthly doses is non-inferior to aflibercept 2 mg monthly with respect to mean change in best corrected visual acuity (BCVA).
- Efficacy of KSI-301 5 mg compared to aflibercept 2 mg based on changes in BCVA and CST. [ Time Frame: Day 1 to Week 44 ]Improvement in best corrected visual acuity (BCVA) and central subfield thickness (CST) between the two treatment arms.
- Durability of KSI-301 5 mg compared to aflibercept 2 mg based on number of intravitreal injections during the study. [ Time Frame: Week 1 to Week 44 ]Mean number of intravitreal injections during the course of the study between the two treatment arms.
- Safety and Tolerability of KSI-301 5 mg compared to aflibercept 2 mg based on the number of ocular and systemic adverse events. [ Time Frame: Day 1 to Week 76 ]Incidence of ocular and systemic adverse events up to Week 24, Week 52, and Week 76
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Signed informed consent prior to participation in the study.
- Treatment-naïve macular edema of 6 months duration or less due to CRVO or BRVO. Participants with hemiretinal vein occlusion will be included as CRVO.
- BCVA ETDRS letter score between 80 and 25 (20/25 to 20/320 Snellen equivalent), inclusive in the Study Eye.
- CST of ≥ 320 microns on SD-OCT (Heidelberg Spectralis or equivalent on other OCT instruments) as determined by the Reading Center
- Decrease in vision determined by the Investigator to be primarily the result of ME secondary to RVO.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
- Macular edema in the Study Eye for reasons other than RVO
- Active iris or angle neovascularization, neovascular glaucoma, neovascularization of the optic disc, retinal neovascularization or vitreous hemorrhage in the Study Eye.
- Uncontrolled glaucoma in the Study Eye.
- Active retinal disease other than the condition under investigation in the Study Eye.
- Any history or evidence of a concurrent ocular condition present, that in the opinion of the Investigator could require either medical or surgical intervention alter visual acuity during the study
- Active or suspected ocular or periocular infection or inflammation
- Any prior use of an approved or investigational treatment for macular edema secondary to RVO in the Study Eye (e.g. anti-VEGF, intraocular or periocular steroids, macular laser photocoagulation).
- Women who are pregnant or lactating or intending to become pregnant during the study.
- Uncontrolled blood pressure defined as a systolic value ≥ 180 mmHg or diastolic value ≥100 mmHg while at rest
- Recent history (within the 6 months prior to screening) of myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure or any acute coronary event.
- History of a medical condition that, in the judgment of the Investigator, would preclude scheduled study visits, completion of the study, or a safe administration of investigational product.
- Other protocol-specified exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04592419
Show 141 study locations
| Study Director: | Daniel Janer, MD | Kodiak Sciences Inc |
| Responsible Party: | Kodiak Sciences Inc |
| ClinicalTrials.gov Identifier: | NCT04592419 |
| Other Study ID Numbers: |
KS301P103 2020-001061-37 ( EudraCT Number ) |
| First Posted: | October 19, 2020 Key Record Dates |
| Last Update Posted: | February 9, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
|
RVO Kodiak KSI-301 Vascular endothelial growth factor Anti-VEGF VEGF Antibody biopolymer conjugate |
Retinal Degeneration Retinal Diseases Eye Diseases Vision Disorders Vision, low Aflibercept Eylea |
|
Macular Edema Retinal Vein Occlusion Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Venous Thrombosis Thrombosis Embolism and Thrombosis |
Vascular Diseases Cardiovascular Diseases Aflibercept Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Antineoplastic Agents |