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

NCT03249740 | Completed Phase 1 FDA Drug

• 1 other identifier: GBV-102-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Age-related macular degeneration; Choroidal neovascularization

Outcome Measures

Primary Outcomes (2)

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

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

  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)

  Baseline, Month 9

Secondary Outcomes (17)

• Phase 1: Change from baseline in BCVA by ETDRS

  8 months

• Phase 1: Change from baseline in sub-retinal thickness

  8 months

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

  8 months

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

  8 months

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

  8 months

Study Arms (3)

Experimental: Phase 1 - GB-102

EXPERIMENTAL

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.

Drug: GB-102

Experimental: Phase 2 - GB-102

EXPERIMENTAL

Low dose or high dose injected every 6 months

Drug: GB-102

Active Comparator: Phase 2 - Aflibercept

ACTIVE COMPARATOR

Aflibercept 2 mg injected every 2 months

Drug: Aflibercept

Interventions

GB-102 DRUG

Intravitreal injection of GB-102

Also known as: Sunitinib malate

Experimental: Phase 1 - GB-102; Experimental: Phase 2 - GB-102

Aflibercept DRUG

Intravitreal injection of Aflibercept.

Also known as: Anti-VEGF

Active Comparator: Phase 2 - Aflibercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females of any race, ≥ 50 years of age
• 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)
• Evidence of increased vascular permeability and/or loss of visual acuity

You may not qualify if:

• 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
• Uncontrolled hypertension, diabetes mellitus, IOP, hypothyroidism, or hyperthyroidism
• Chronic renal disease
• Abnormal liver function
• Women who are pregnant or lactating

Sponsors & Collaborators

• Graybug Vision: lead

Study Sites (8)

Retinal Consultants of Arizona

Gilbert, Arizona, 85296, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46290, United States

Location

Ophthalmic Consultants of Long Island

Lynbrook, New York, 11563, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Texas Retina Associates

Arlington, Texas, 76012, United States

Location

Retina Research Center, PLLC

Austin, Texas, 78705, United States

Location

Medical Center Ophthalmology Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Sunitinib; aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Charles P. Semba, MD

  Graybug Vision, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking is relevant to Phase 2 only
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 15, 2017
• Study Start: August 29, 2017
• Primary Completion: September 13, 2018
• Study Completion: January 16, 2019
• Last Updated: December 20, 2019

Record last verified: 2019-12

Locations

US (8)