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

NCT ID: NCT03249740

Last Updated: 2019-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-29

Study Completion Date

2019-01-16

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Neovascular Age-Related Macular Degeneration

Keywords

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Age-related macular degeneration Choroidal neovascularization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Masking is relevant to Phase 2 only

Study Groups

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Experimental: Phase 1 - GB-102

Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102.

Group Type EXPERIMENTAL

GB-102

Intervention Type DRUG

Intravitreal injection of GB-102

Experimental: Phase 2 - GB-102

Low dose or high dose injected every 6 months

Group Type EXPERIMENTAL

GB-102

Intervention Type DRUG

Intravitreal injection of GB-102

Active Comparator: Phase 2 - Aflibercept

Aflibercept 2 mg injected every 2 months

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

Intravitreal injection of Aflibercept.

Interventions

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GB-102

Intravitreal injection of GB-102

Intervention Type DRUG

Aflibercept

Intravitreal injection of Aflibercept.

Intervention Type DRUG

Other Intervention Names

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Sunitinib malate Anti-VEGF

Eligibility Criteria

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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

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Graybug Vision

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charles P. Semba, MD

Role: STUDY_DIRECTOR

Graybug Vision, Inc.

Locations

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Retinal Consultants of Arizona

Gilbert, Arizona, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Midwest Eye Institute

Indianapolis, Indiana, United States

Site Status

Ophthalmic Consultants of Long Island

Lynbrook, New York, United States

Site Status

Retina Research Institute of Texas

Abilene, Texas, United States

Site Status

Texas Retina Associates

Arlington, Texas, United States

Site Status

Retina Research Center, PLLC

Austin, Texas, United States

Site Status

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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GBV-102-001

Identifier Type: -

Identifier Source: org_study_id