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

Официальное название

A Phase 2 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)

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат EYE103
  EYE103 is a humanized antibody formulated for intravitreal administration
• Препарат Aflibercept 2.0 mg
  Aflibercept 2.0 mg is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with Neovascular Age-Related Macular Degeneration (NVAMD). Aflibercept 2.0 mg is only administered to 2 cohorts of Incomplete Responders (IR) with NVAMD in combination with Low Dose or High Dose EYE103.

Первичные конечные точки

• Change from baseline in Best-Corrected Visual Acuity measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart [Срок оценки: Week 12]

Вторичные конечные точки (2)

• Changes in retinal central subfield thickness (CST) based on spectral domain optical coherence tomography (SDOCT) [Срок оценки: Duration of the study, through Week 12]
• Changes in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart [Срок оценки: Duration of the study, through Week 12]

Критерии участия

Критерии включения

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

Key Neovascular Age-related Macular Degeneration (NVAMD)-specific Inclusion Criteria

• Be ≥ 50 years of age
• Have treatment naive subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (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 Incomplete Responder (IR) NVAMD-specific Inclusion Criteria

• Be ≥ 50 years of age
• Have subfoveal CNV secondary to AMD or juxtafoveal/extrafoveal CNV with foveal involvement at initial screening
• For participants who are treatment experienced for NVAMD, the diagnosis must have been made within 90 days prior to the Screening Visit 2

Key Branch Retinal Vein Occlusion (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

Критерии исключения

Key General Exclusion Criteria

• 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
• 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, diabetic macular edema, NVAMD, Irvine-Gass syndrome)
• Have active iris or angle neovascularization or neovascular glaucoma in the study eye

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 49 центров

• Scottsdale, Arizona — Scottsdale
• Scottsdale, AZ — Scottsdale
• Glendale, California — Glendale
• Glendale, CA — Glendale
• Modesto, California — Modesto
• Mountain View, California — Mountain View
• Sacramento, CA — Sacramento
• Sactamento, California — Sacramento
• … и ещё 41 центр

Идентификаторы

NCT: NCT07205887 · EYE-RES-104

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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