NCT04085341

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2019

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

September 11, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 15, 2021

Completed
Last Updated

November 22, 2021

Status Verified

November 1, 2021

Enrollment Period

9 months

First QC Date

September 9, 2019

Results QC Date

May 27, 2021

Last Update Submit

November 18, 2021

Conditions

Diabetic Macular EdemaRetina Vein Occlusion

Keywords

Macular Edema

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Adverse Events (AEs) Across All Study Visits

    Number of subjects with an adverse event across all study visits

    Baseline through Month 6

Secondary Outcomes (3)

  • Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits

    Baseline to Month 6

  • Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits

    Baseline to Month 6

  • Time to Rescue Treatment

    Baseline through Month 6

Study Arms (2)

GB-102 Dose 1 (1 mg)

EXPERIMENTAL

Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.

Drug: GB-102

GB-102 Dose 2 (2 mg)

EXPERIMENTAL

Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

Drug: GB-102

Interventions

GB-102DRUG

Intravitreal injection of GB-102

Also known as: Sunitinib malate
GB-102 Dose 1 (1 mg)GB-102 Dose 2 (2 mg)

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Retinal Research Institute

Phoenix, Arizona, 85053, United States

Location

Southern Retina

Savannah, Georgia, 31405, United States

Location

Eye Care Institute

Louisville, Kentucky, 40206, United States

Location

Boston Retina

Boston, Massachusetts, 02482, United States

Location

Sierra Eye Associates

Reno, Nevada, 89502, United States

Location

Texoma Retina Center

Denison, Texas, 75020, United States

Location

MeSH Terms

Conditions

Macular Edema

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Limitations and Caveats

Too few subject numbers divided across multiple indications. The trial was conducted in 21 subjects with Diabetic Macular Edema, Branch Retinal Vein Occlusion and Central Retinal Vein Occlusion divided between two doses. Subjects had variable disease control and duration prior to entry.

Results Point of Contact

Title
Director, Global Clinical Development Operations
Organization
Graybug Vision
bpatel@graybug.vision
5622098872

Study Officials

  • Chief Medical Officer

    Graybug Vision, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Open-label study design
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel-arm design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2019

First Posted

September 11, 2019

Study Start

September 11, 2019

Primary Completion

June 5, 2020

Study Completion

June 5, 2020

Last Updated

November 22, 2021

Results First Posted

July 15, 2021

Record last verified: 2021-11

Locations

US(6)