Diabetic Macular EdemaPhase 2NCT04085341

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

A Phase 2 study testing GB-102 in people with Diabetic Macular Edema and Retina Vein Occlusion, run by Graybug Vision at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Diabetic Macular Edema, Retina Vein Occlusion
What is being tested?: GB-102
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 6 sitesUnited States
Study dates: 11 Sep 2019to 5 Jun 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Boston Retina
Boston, Massachusetts, 02482
Texoma Retina Center
Denison, Texas, 75020
Eye Care Institute
Louisville, Kentucky, 40206
Retinal Research Institute
Phoenix, Arizona, 85053
Sierra Eye Associates
Reno, Nevada, 89502
Southern Retina
Savannah, Georgia, 31405

Other trials in United States

About this study

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)

Read the 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)

Conditions: Diabetic Macular Edema, Retina Vein Occlusion
Being tested: GB-102
Keywords: Macular Edema
Medical subject headings: Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GB-102Drug
Also called Sunitinib malate
Intravitreal injection of GB-102

Study groups in NCT04085341
Study group	Role	What they receive
GB-102 Dose 1 (1 mg)	Experimental	Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline. Receives: 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. Receives: Drug: GB-102

What is being measured

The primary outcome is the main question the study is designed to answer.

Occurrence of Adverse Events (AEs) Across All Study Visits
Number of subjects with an adverse event across all study visits
Measured: Baseline through Month 6

Secondary outcomes (3)

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy
BCVA = 0 (worst) to 100 (best)
Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
Measured: Baseline to Month 6
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
CST = central subfield thickness
SD-OCT = spectral domain-optical coherence tomography
Assessment of change in CST (μm) measurement from baseline at all visits
Measured: Baseline to Month 6
Time to Rescue Treatment
Assessment of time to rescue treatment over 6 months of treatment
Measured: Baseline through Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Sep 20195 Jun 2020

First posted11 Sep 2019
Study start11 Sep 2019
Primary completion5 Jun 2020
Study completion5 Jun 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: Parallel-arm design
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04085341
Sponsor's protocol ID: GBV-102-003
Status last verified: Nov 2021
First submitted: 9 Sep 2019
Last updated: 22 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04085341
Acronym / sponsor ID: GBV-102-003
Conditions: Diabetic Macular Edema, Retina Vein Occlusion
Keywords: Macular Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Graybug VisionIndustry (pharma, biotech, devices)
Study start: 11 Sep 2019 (actual)
Primary completion: 5 Jun 2020 (actual)
Study completion: 5 Jun 2020 (actual)
First posted: 11 Sep 2019 (actual)
Results: Posted 15 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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)

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Parallel-arm design

Arm	Type	Receives
GB-102 Dose 1 (1 mg)	Experimental	Drug: GB-102Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline.
GB-102 Dose 2 (2 mg)	Experimental	Drug: GB-102Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline.

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GB-102Also: Sunitinib malateIntravitreal injection of GB-102	Drug	GB-102 Dose 1 (1 mg), GB-102 Dose 2 (2 mg)

Primary outcome

Occurrence of Adverse Events (AEs) Across All Study Visits
Time frame: Baseline through Month 6
Number of subjects with an adverse event across all study visits

3 secondary outcomes

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) (ETDRS) at All Study Visits
Time frame: Baseline to Month 6
Mean Change From Baseline in Central Subfield Thickness (CST) (SD-OCT) at All Study Visits
Time frame: Baseline to Month 6
Time to Rescue Treatment
Time frame: Baseline through Month 6

Results and safety

Results posted to the registry on 15 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GB-102 Dose 1 (1 mg)	10	10
GB-102 Dose 2 (2 mg)	11	11

Primary outcome: Occurrence of Adverse Events (AEs) Across All Study Visits

Time frame: Baseline through Month 6. Count of participants. Unit: Participants

Measure	GB-102 Dose 1 (1 mg) n = 10	GB-102 Dose 2 (2 mg) n = 11
Value	7	10

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected from baseline for the duration of a subject's participation in the study (up to 180 days). AEs are reported as treatment-emergent.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GB-102 Dose 1 (1 mg)	1 of 10 (10%)	7 of 10 (70%)	0 of 10
GB-102 Dose 2 (2 mg)	2 of 11 (18.2%)	10 of 11 (90.9%)	0 of 11

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Chief Medical Officer study director

Graybug Vision, Inc.

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB-102 in people with Diabetic Macular Edema and Retina Vein Occlusion, run by Graybug Vision at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Adverse Events (AEs) Across All Study Visits (time frame: Baseline through Month 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04085341.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2021.