Trials / Completed
CompletedNCT03249740
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Graybug Vision · Industry
- Sex
- All
- Age
- 50 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GB-102 | Intravitreal injection of GB-102 |
| DRUG | Aflibercept | Intravitreal injection of Aflibercept. |
Timeline
- Start date
- 2017-08-29
- Primary completion
- 2018-09-13
- Completion
- 2019-01-16
- First posted
- 2017-08-15
- Last updated
- 2019-12-20
Locations
8 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03249740. Inclusion in this directory is not an endorsement.