A Dose-masked Study of Intravitreal EYE103 in Participants With NVAMD or Macular Edema Following BRVO (Super Tuscan)

EyeBiotech

Status and phase: Enrolling; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration (NVAMD); Branch Retinal Vein Occlusion (BRVO)

Treatments: Drug: EYE103; Drug: Aflibercept 2.0 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT07205887

EYE-RES-104

Details and patient eligibility

About

EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).

The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT. 40 participants will be enrolled in each cohort. Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.

All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. All participants will return at designated time points following each injection for safety and efficacy assessments. The Week 12 Visit will serve as the end of study visit for all participants.

Full description

EYE-RES-104 is a randomized, dose-masked study of intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO).

The study will consist of 4 patient cohorts, with participants in each cohort randomized (1:1) to either a low dose of EYE103 via IVT or a high dose of EYE103 via IVT:

• one cohort of 40 treatment naïve NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy),
• one cohort of 40 incomplete responder (IR) NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy),
• one cohort of 40 IR NVAMD participants will be randomized (1:1) to 1 of the 2 doses of EYE103, to be administered in combination with aflibercept 2.0 mg
• one cohort of 40 treatment naïve BRVO participants will be randomized (1:1) to 1 of the 2 doses of EYE103 (as monotherapy)

Enrollment timing for each cohort will be sequenced into specific arms of the study at the Sponsor's discretion.

All participants in the study will receive a total of 3 injections of EYE103 into the study eye, spaced at 4 weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg in the study eye on Day 1.

All participants will be assessed for safety and efficacy at injection visits. Treatment naïve NVAMD participants and IR NVAMD participants in the monotherapy cohort will also return 2 weeks after each injection visit for safety and efficacy assessments. Depending on the cohort, participants will be evaluated every 2 weeks or every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns. The Week 12 Visit will serve as the end of study visit for all participants.

Enrollment: 160 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Key General Inclusion Criteria

• Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
• Be male or female ≥18 years of age.

Key NVAMD-specific Inclusion Criteria

• Be ≥ 50 years of age
• Have treatment naive subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement
• For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Day 1 study treatment

Key IR NVAMD-specific Inclusion Criteria

• Be ≥ 50 years of age
• Have treatment naive subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
• For participants who are treatment naïve for NVAMD, the diagnosis must have been made within 21 days prior to the Screening Visit 2

Key BRVO-specific Inclusion Criteria

• Be diagnosed with BRVO in the study eye
• Have a decrease in vision in the study eye determined by the Investigator to be primarily the result of BRVO
• Be treatment naïve with vision loss in the study eye and have center-involving macular edema diagnosed within 9 months of Screening

Exclusion criteria

Key General Exclusion Criteria

• Be pregnant or breastfeeding
• History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
• Have had Yttrium-Aluminum Garnet (YAG) laser capsulotomy in the study eye within 90 days of Screening
• Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)

Key NVAMD-specific Exclusion Criteria

• Have had previous thermal subfoveal laser therapy in the study eye
• Have had previous photodynamic therapy with Visudyne in the study eye

Key BRVO-specific Exclusion Criteria

• Have macular edema in the study eye considered to be secondary to a cause other than BRVO (eg, DME, NVAMD, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 8 patient groups

Treatment Naïve NVAMD - Low Dose EYE103

Experimental group

Description:

Treatment Naïve NVAMD Cohort - Low Dose EYE103 (50 μL)

Treatment:

Drug: EYE103

Treatment Naïve NVAMD - High Dose EYE103

Experimental group

Description:

Treatment Naïve NVAMD Cohort - High Dose EYE103 (50 μL)

Treatment:

Drug: EYE103

IR NVAMD - Low Dose EYE103

Experimental group

Description:

Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL)

Treatment:

Drug: EYE103

IR NVAMD - High Dose EYE103

Experimental group

Description:

Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL)

Treatment:

Drug: EYE103

IR NVAMD - Low Dose EYE103 in combination with Aflibercept 2.0 mg

Experimental group

Description:

Incomplete Responder (IR) NVAMD Cohort - Low Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg

Treatment:

Drug: Aflibercept 2.0 mg

Drug: EYE103

IR NVAMD - High Dose EYE103 in combination with Aflibercept 2.0 mg

Experimental group

Description:

Incomplete Responder (IR) NVAMD Cohort - High Dose EYE103 (50 μL) in combination with Aflibercept 2.0 mg

Treatment:

Drug: Aflibercept 2.0 mg

Drug: EYE103

Treatment Naïve BRVO - Low Dose EYE103

Experimental group

Description:

Treatment Naïve BRVO Cohort - Low Dose EYE103 (50 μL)

Treatment:

Drug: EYE103

Treatment Naïve BRVO - High Dose EYE103

Experimental group

Description:

Treatment Naïve BRVO Cohort - High Dose EYE103 (50 μL)

Treatment:

Drug: EYE103