A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration

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Overview

The purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.

In this 2-part study, Part 1 is a multicenter, open-label, safety, tolerability, and systemic exposure evaluation to Sunitinib in escalating doses of a single IVT injection of GB-102, while Part 2 is a multicenter, double-masked, randomized (1:1:1), parallel-group, safety, and efficacy evaluation of repeated IVT injections of 2 dose levels of GB-102 compared with aflibercept.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Neovascular Age-Related Macular Degeneration

Interventions

GB-102DRUG

Intravitreal injection of GB-102

AfliberceptDRUG

Intravitreal injection of Aflibercept.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Males or females of any race, ≥ 50 years of age 2. Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab) 3. Evidence of increased vascular permeability and/or loss of visual acuity Key Exclusion Criteria: 1. History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke 2. Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism 3. Chronic renal disease 4. Abnormal liver function 5. Women who are pregnant or lactating

Locations (8)

Retinal Consultants of Arizona

Gilbert, Arizona, United States

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Midwest Eye Institute

Indianapolis, Indiana, United States

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Outcomes

Primary Outcomes

Phase 1: Occurrence of ocular and nonocular adverse events (AEs)

Number of adverse events in total and number of subjects with an adverse event

Time frame: 8 months

Phase 2: Change from baseline in best corrected visual acuity by ETDRS

Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)

Time frame: Baseline, Month 9

Secondary Outcomes

Phase 1: Change from baseline in BCVA by ETDRS

Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method

Time frame: 8 months

Phase 1: Change from baseline in sub-retinal thickness

Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)

Time frame: 8 months

Phase 1: Change from baseline in retinal fluid by SD-OCT

Assessment of retinal fluid by SD-OCT

Time frame: 8 months

Phase 1: Change from baseline in total lesion area by FA/CFP

Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)

Time frame: 8 months

Phase 1: Change from baseline in CNV lesion area by FA/CFP

CNV lesion area by FA/CFP

Time frame: 8 months

Phase 1: Change from baseline in fluorescein leakage area by FA/CFP

Data from ClinicalTrials.gov

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