Clinical trial NCT04085341: A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion
Official title: A Phase 2a Multicenter Study Evaluating the Safety, Tolerability, and Pharmacodynamics of Sunitinib Malate Depot Formulation (GB-102) in Subjects With Diabetic Macular Edema (DME) and Retinal Vein Occlusion (RVO)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Retina Vein Occlusion
Keywords: Macular Edema
Lead sponsor: Graybug Vision
Sponsor class: INDUSTRY
First posted: 2019-09-11
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel-arm design
Primary purpose: TREATMENT

Brief summary: Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion

Detailed description: Phase 2a multicenter, open-label, parallel-arm design study to evaluate the safety, tolerability and pharmacodynamics of a single intravitreal injection comparing 2 dose levels (1 mg and 2 mg) of GB-102 on subjects with Diabetic Macular Edema and Retinal Vein Occlusion who have received prior treatment with anti-vascular endothelial growth factor (VEGF)

Eligibility criteria: Inclusion Criteria:

* Males or females ≥ 21 years of age
* Known diagnosis of macular edema secondary to diabetic macular edema or retinal vein occlusion treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
* Demonstrated response to prior anti-VEGF treatment since diagnosis
* BCVA of 31 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 IOP
* Chronic renal disease

Primary outcomes:
measure: Occurrence of Adverse Events (AEs) Across All Study Visits
timeFrame: Baseline through Month 6
Secondary outcomes:
measure: Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
timeFrame: Baseline to Month 6
measure: Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
timeFrame: Baseline to Month 6
measure: Time to Rescue Treatment
timeFrame: Baseline through Month 6
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Research Institute
state: Arizona
city: Savannah
country: United States
facility: Southern Retina
state: Georgia
city: Louisville
country: United States
facility: Eye Care Institute
state: Kentucky
city: Boston
country: United States
facility: Boston Retina
state: Massachusetts
city: Reno
country: United States
facility: Sierra Eye Associates
state: Nevada
city: Denison
country: United States
facility: Texoma Retina Center
state: Texas
Study officials:
affiliation: Graybug Vision, Inc.
name: Chief Medical Officer
role: STUDY_DIRECTOR
References: