A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. (DAZZLE)

Kodiak Sciences

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Wet Macular Degeneration

Treatments: Drug: Aflibercept; Drug: KSI-301; Other: Sham Procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04049266

KSI-CL-102

Details and patient eligibility

About

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).

Full 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.

Enrollment: 559 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent prior to participation in the study.
• Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD.
• BCVA ETDRS score between 80 and 25 letters (Snellen equivalent of 20/25 to 20/320), inclusive.
• Other protocol-specified inclusion criteria may apply

Exclusion criteria

• CNV secondary to other causes in the Study Eye.
• Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid.
• Any history or evidence of a concurrent intraocular condition in the Study Eye that, in the judgment of the Investigator, could require either medical or surgical intervention during the study to prevent or treat visual loss.
• Active ocular or periocular infection or inflammation.
• Prior administration of any approved or investigational treatment for neovascular AMD in the Study Eye.
• Uncontrolled glaucoma in the Study Eye.
• Women who are pregnant or lactating or intending to become pregnant during the study.
• Stroke or myocardial infarction in the 6-month period prior to Day 1.
• Uncontrolled blood pressure defined as a systolic value > 180 mmHg or diastolic value ≥100 mmHg while at rest.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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559 participants in 2 patient groups

KSI-301 5 mg

Experimental group

Description:

Drug: KSI-301 5 mg. KSI-301 5 mg will be administered by intravitreal injection into the study eye at 12, 16, and 20 weeks intervals as specified in the study protocol. Drug: 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.

Treatment:

Other: Sham Procedure

Drug: KSI-301

Aflibercept 2 mg

Active Comparator group

Description:

Drug: Aflibercept 2 mg. Aflibercept 2 mg will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks. Drug: 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.

Treatment:

Other: Sham Procedure

Drug: Aflibercept