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

Graybug Vision

Status and phase: Completed; Phase 2

Conditions: Neovascular Age-Related Macular Degeneration

Treatments: Drug: Drug: GB-102; Drug: Aflibercept

Study type: Interventional

Funder types: Industry

Identifiers

NCT03953079

GBV-102-002

Details and patient eligibility

About

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.

Full 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

Enrollment: 56 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 3 patient groups

GB-102 1 mg/1 mg

Experimental group

Description:

Participants will receive intravitreal (IVT) GB-102 1 mg in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.

Treatment:

Drug: Drug: GB-102

GB-102 2 mg/1 mg

Experimental group

Description:

Participants will receive intravitreal (IVT) GB-102 2 mg in the study eye at Baseline, intravitreal (IVT) GB-102 1 mg at Month 6 and sham at Months 2, 4, 8 and 10.

Treatment:

Drug: Drug: GB-102

Aflibercept 2 mg

Active Comparator group

Description:

Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.

Treatment:

Drug: Aflibercept