Clinical trial NCT03249740: A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
Official title: A Phase 1/2 Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of an Intravitreal Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age-Related Macular Degeneration
Keywords: Age-related macular degeneration
Choroidal neovascularization
Lead sponsor: Graybug Vision
Sponsor class: INDUSTRY
First posted: 2017-08-15
Enrollment: 32
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
timeFrame: 8 months
measure: Phase 2: Change from baseline in best corrected visual acuity by ETDRS
timeFrame: Baseline, Month 9
Secondary outcomes:
measure: Phase 1: Change from baseline in BCVA by ETDRS
timeFrame: 8 months
measure: Phase 1: Change from baseline in sub-retinal thickness
timeFrame: 8 months
measure: Phase 1: Change from baseline in retinal fluid by SD-OCT
timeFrame: 8 months
measure: Phase 1: Change from baseline in total lesion area by FA/CFP
timeFrame: 8 months
measure: Phase 1: Change from baseline in CNV lesion area by FA/CFP
timeFrame: 8 months
measure: Phase 1: Change from baseline in fluorescein leakage area by FA/CFP
timeFrame: 8 months
measure: Phase 1: Rescue medication
timeFrame: 8 months
measure: Phase 1: Systemic exposure to sunitinib measured in plasma level
timeFrame: 8 months
measure: Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height
timeFrame: 8 months
measure: Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT
timeFrame: 12 months
measure: Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS
timeFrame: 12 months
measure: Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS
timeFrame: 12 months
measure: Phase 2: Occurrence of ocular and nonocular adverse events (AEs)
timeFrame: 12 months
measure: Phase 2: Change from baseline in BCVA by ETDRS
timeFrame: 12 months
measure: Phase 2: Systemic exposure to sunitinib measured in plasma level
timeFrame: 12 months
measure: Phase 2: Change from baseline in sub-retinal thickness
timeFrame: 12 months
measure: Phase 2: Rescue medication
timeFrame: 12 months
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Indianapolis
country: United States
facility: Midwest Eye Institute
state: Indiana
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Arlington
country: United States
facility: Texas Retina Associates
state: Texas
city: Austin
country: United States
facility: Retina Research Center, PLLC
state: Texas
city: San Antonio
country: United States
facility: Medical Center Ophthalmology Associates
state: Texas
Study officials:
affiliation: Graybug Vision, Inc.
name: Charles P. Semba, MD
role: STUDY_DIRECTOR
References: