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

Neovascular Age-Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03249740
• Other study ID #: GBV-102-001
• Status: Completed
• Phase: Phase 1
• Start date: August 29, 2017
• Est. completion date: January 16, 2019

Study information

• Verified date: December 2019
• Source: Graybug Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 16, 2019
• Est. primary completion date: September 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• GB-102
Intravitreal injection of GB-102
• Aflibercept
Intravitreal injection of Aflibercept.

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Texas Retina Associates	Arlington	Texas
United States	Retina Research Center, PLLC	Austin	Texas
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Retinal Consultants of Arizona	Gilbert	Arizona
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	Ophthalmic Consultants of Long Island	Lynbrook	New York
United States	Medical Center Ophthalmology Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Graybug Vision

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Phase 1: Change from baseline in BCVA by ETDRS	Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method	8 months
Secondary	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)	8 months
Secondary	Phase 1: Change from baseline in retinal fluid by SD-OCT	Assessment of retinal fluid by SD-OCT	8 months
Secondary	Phase 1: Change from baseline in total lesion area by FA/CFP	Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)	8 months
Secondary	Phase 1: Change from baseline in CNV lesion area by FA/CFP	CNV lesion area by FA/CFP	8 months
Secondary	Phase 1: Change from baseline in fluorescein leakage area by FA/CFP	Area of fluorescein leakage by FA/CFP	8 months
Secondary	Phase 1: Rescue medication	Proportion of subjects receiving rescue medication and median time to rescue medication	8 months
Secondary	Phase 1: Systemic exposure to sunitinib measured in plasma level	Plasma levels of sunitinib (ng/mL)	8 months
Secondary	Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height	Subretinal hyper reflective material (SHRM) height	8 months
Secondary	Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT	Assessment of retinal fluid by SD-OCT	12 months
Secondary	Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS	Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12	12 months
Secondary	Phase 2: Proportion of subjects with = 15 BCVA letters gained by ETDRS	Proportion of subjects with = 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12	12 months
Secondary	Phase 2: Occurrence of ocular and nonocular adverse events (AEs)	Number of adverse events in total and number of subjects with an adverse event	12 months
Secondary	Phase 2: Change from baseline in BCVA by ETDRS	Mean change from baseline in mean BCVA measured by early treatment	12 months
Secondary	Phase 2: Systemic exposure to sunitinib measured in plasma level	Plasma levels of sunitinib (ng/mL)	12 months
Secondary	Phase 2: Change from baseline in sub-retinal thickness	Mean change from baseline in sub-retinal thickness (microns) by SD-OCT	12 months
Secondary	Phase 2: Rescue medication	Proportion of subjects receiving rescue medication and median time to rescue medication	12 months