Phase 2 Completed N=21 Treatment

A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Diabetic Macular Edema and Retinal Vein Occlusion

Diabetic Macular Edema · Retina Vein Occlusion

Source: ClinicalTrials.gov NCT04085341 ↗

Enrolled (actual)

Serious AEs

14.3%

Results posted

Jul 2021

Primary outcomePrimary: Occurrence of Adverse Events (AEs) Across All Study Visits — 7; 10 Participants

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Occurrence of Adverse Events (AEs) Across All Study Visits	7; 10	—
SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits	-10.4; -16.7	—
SECONDARY Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits	131.0; -37.4	—
SECONDARY Time to Rescue Treatment	90; 120	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04085341). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.