A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Neovascular Age-Related Macular Degeneration Clinical Trial

— ALTISSIMO  

Official title:

A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03953079
• Other study ID #: GBV-102-002
• Status: Completed
• Phase: Phase 2
• Start date: September 26, 2019
• Est. completion date: June 3, 2021

Study information

• Verified date: January 2022
• Source: Graybug Vision
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

Description:

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)

Extension Study:

To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 3, 2021
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Males or females = 50 years of age

• Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).

• Demonstrated response to prior anti-VEGF treatment since diagnosis

• Best-corrected visual acuity (BCVA) of 35 letters or better

Exclusion Criteria:

• 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 or intraocular pressure (IOP)

• Chronic renal disease

• Abnormal liver function

• Women who are pregnant or lactating

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-Related Macular Degeneration

Intervention

Drug:
• Drug: GB-102
Intravitreal injection of GB-102
• Aflibercept
Intravitreal injection of aflibercept (2 mg dose)

Locations

Country	Name	City	State
United States	Retina Consultants of Hawaii	'Aiea	Hawaii
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Southeast Retina Center	Augusta	Georgia
United States	Austin Retina Associates	Austin	Texas
United States	Retina Research Center, PLLC	Austin	Texas
United States	California Retina Research Consultants	Bakersfield	California
United States	Retinal Diagnostic Center of Northern California	Campbell	California
United States	Sterling Research	Cincinnati	Ohio
United States	Specialty Retina Center	Coral Springs	Florida
United States	Wolfe Eye Clinic - West Des Moines	Des Moines	Iowa
United States	The Retina Partners	Encino	California
United States	Retina Consultants of Orange County	Fullerton	California
United States	Retinal Consultants AZ	Gilbert	Arizona
United States	Cumberland Valley Retina Consultants	Hagerstown	Maryland
United States	Mid Atlantic Retina Specialists	Hagerstown	Maryland
United States	University Retina and Macula	Lemont	Illinois
United States	Piedmont Eye Center	Lynchburg	Virginia
United States	Northern California Retina Vitreous Associates Medical Group, Inc.	Mountain View	California
United States	Ophthalmic Consultants of Long Island	Oceanside	New York
United States	Florida Retina Institute	Orlando	Florida
United States	Retina Specialty Institute	Pensacola	Florida
United States	Retinal Research Institute	Phoenix	Arizona
United States	Eye Associates of Pinellas	Pinellas Park	Florida
United States	Retina Specialists	Plano	Texas
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Sierra Eye Associates	Reno	Nevada
United States	West Coast Retina Medical Group, Inc.	San Francisco	California
United States	California Retina Consultants - CRC	Santa Barbara	California
United States	Retina Center NW PLLC	Silverdale	Washington
United States	Retina Consultants of Houston	The Woodlands	Texas
United States	Bay Area Retina Associates	Walnut Creek	California
United States	Eye Associates of Northeast Louisiana	West Monroe	Louisiana
United States	Strategic Clinical Research Group LLC	Willow Park	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	Time to First Rescue Treatment	Kaplan-Meier estimate of the median time to first rescue treatment.	Baseline through 12 months
Secondary	Time to Fulfillment of at Least One Rescue Criterion	Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit	6 months through 12 months
Secondary	Number of Times That at Least One Rescue Criterion is Met	Assessment of the number of monthly intervals that at least one rescue criterion is met	Baseline through 12 months
Secondary	Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study	Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study	Baseline through 12 months
Secondary	Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits	BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy; BCVA ETDRS range = 0 (worst) to 100 (best); Assessment of change in BCVA (ETDRS letter score) from baseline at all visits	Baseline through 12 months
Secondary	Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits	BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy; BCVA ETDRS range = 0 (worst) to 100 (best); Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits	Baseline through 12 months
Secondary	Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits	Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits; A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.	Baseline through 12 months
Secondary	Change From Baseline in Central Subfield Thickness (CST) (µm) at All Visits	CST = central subfield thickness; Assessment of change in CST (µm) measurement from baseline at all visits	Baseline through 12 months
Secondary	Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits	Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits	Baseline through 12 months