Neovascular Age-Related Macular DegenerationPhase 1NCT03249740
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related Macular Degeneration
A Phase 1 study testing GB-102 and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Graybug Vision at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration
- What is being tested?
- GB-102 and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 8 sitesUnited States
- Study dates
- 29 Aug 2017to 16 Jan 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females of any race, ≥ 50 years of age
- Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
- Evidence of increased vascular permeability and/or loss of visual acuity
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, IOP, hypothyroidism, or hyperthyroidism
- Chronic renal disease
- Abnormal liver function
- Women who are pregnant or lactating
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
Texas Retina Associates
Arlington, Texas, 76012
Retina Research Center, PLLC
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retinal Consultants of Arizona
Gilbert, Arizona, 85296
Midwest Eye Institute
Indianapolis, Indiana, 46290
Ophthalmic Consultants of Long Island
Lynbrook, New York, 11563
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240
About this study
Official title: 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
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.
Read the 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.
- Being tested
- GB-102, Aflibercept
- Keywords
- Age-related macular degeneration, Choroidal neovascularization
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization
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
AfliberceptDrug
Also called Anti-VEGF
Intravitreal injection of Aflibercept.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Phase 1 - GB-102 | Experimental | Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102. Receives: Drug: GB-102 |
| Experimental: Phase 2 - GB-102 | Experimental | Low dose or high dose injected every 6 months Receives: Drug: GB-102 |
| Active Comparator: Phase 2 - Aflibercept | Active comparator | Aflibercept 2 mg injected every 2 months Receives: Drug: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
Number of adverse events in total and number of subjects with an adverse event
Measured: 8 months
Phase 2: Change from baseline in best corrected visual acuity by ETDRS
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
Measured: Baseline, Month 9
Secondary outcomes (17)
Phase 1: Change from baseline in BCVA by ETDRS
Mean change from baseline in mean BCVA measured by early treatment diabetic retinopathy (ETDRS) method
Measured: 8 months
Phase 1: Change from baseline in sub-retinal thickness
Mean change from baseline in sub-retinal thickness (microns) by spectral domain - optical coherence tomography (SD-OCT)
Measured: 8 months
Phase 1: Change from baseline in retinal fluid by SD-OCT
Assessment of retinal fluid by SD-OCT
Measured: 8 months
Phase 1: Change from baseline in total lesion area by FA/CFP
Lesion area (total) by fluorescein angiography/color fundus photography (FA/CFP)
Measured: 8 months
Phase 1: Change from baseline in CNV lesion area by FA/CFP
CNV lesion area by FA/CFP
Measured: 8 months
Phase 1: Change from baseline in fluorescein leakage area by FA/CFP
Area of fluorescein leakage by FA/CFP
Measured: 8 months
Phase 1: Rescue medication
Proportion of subjects receiving rescue medication and median time to rescue medication
Measured: 8 months
Phase 1: Systemic exposure to sunitinib measured in plasma level
Plasma levels of sunitinib (ng/mL)
Measured: 8 months
Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height
Subretinal hyper reflective material (SHRM) height
Measured: 8 months
Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT
Assessment of retinal fluid by SD-OCT
Measured: 12 months
Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS
Proportion of subjects with < 15 letters lost in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Measured: 12 months
Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS
Proportion of subjects with ≥ 15 letters gained in BCVA measured by ETDRS method, baseline comparison to assessments at months 1-12
Measured: 12 months
Phase 2: Occurrence of ocular and nonocular adverse events (AEs)
Number of adverse events in total and number of subjects with an adverse event
Measured: 12 months
Phase 2: Change from baseline in BCVA by ETDRS
Mean change from baseline in mean BCVA measured by early treatment
Measured: 12 months
Phase 2: Systemic exposure to sunitinib measured in plasma level
Plasma levels of sunitinib (ng/mL)
Measured: 12 months
Phase 2: Change from baseline in sub-retinal thickness
Mean change from baseline in sub-retinal thickness (microns) by SD-OCT
Measured: 12 months
Phase 2: Rescue medication
Proportion of subjects receiving rescue medication and median time to rescue medication
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2017
- Study start29 Aug 2017
- Primary completion13 Sep 2018
- Study completion16 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Graybug Vision
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles P. Semba, MD, Study director, Graybug Vision, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03249740
- Sponsor's protocol ID
- GBV-102-001
- Status last verified
- Dec 2019
- First submitted
- 2 Aug 2017
- Last updated
- 20 Dec 2019
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03249740
- Acronym / sponsor ID
- GBV-102-001
- Keywords
- Age-related macular degeneration, Choroidal neovascularization
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Graybug VisionIndustry (pharma, biotech, devices)
- Study start
- 29 Aug 2017 (actual)
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 16 Jan 2019 (actual)
- First posted
- 15 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Phase 1: open-label GB-102 dose cohorts are initiated sequentially Phase 2: assignment to and initiation of cohorts occur in parallel - not completed in this study. Separate protocol (GBV-102-002) implemented for Phase 2.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Phase 1 - GB-102 | Experimental | Drug: GB-102Subjects will be assigned to 1 of 4 cohorts to receive a single intravitreal injection of up to 2.0 mg (50 μL) GB-102. |
| Experimental: Phase 2 - GB-102 | Experimental | Drug: GB-102Low dose or high dose injected every 6 months |
| Active Comparator: Phase 2 - Aflibercept | Active comparator | Drug: AfliberceptAflibercept 2 mg injected every 2 months |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females of any race, ≥ 50 years of age
- Presence of an active CNV lesion secondary to AMD treated with at least 3 monthly injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab)
- Evidence of increased vascular permeability and/or loss of visual acuity
Key exclusion criteria (5 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, IOP, hypothyroidism, or hyperthyroidism
- Chronic renal disease
- Abnormal liver function
- Women who are pregnant or lactating
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 | Experimental: Phase 1 - GB-102, Experimental: Phase 2 - GB-102 |
| AfliberceptAlso: Anti-VEGFIntravitreal injection of Aflibercept. | Drug | Active Comparator: Phase 2 - Aflibercept |
Primary outcome
Phase 1: Occurrence of ocular and nonocular adverse events (AEs)
Time frame: 8 months
Number of adverse events in total and number of subjects with an adverse event
Phase 2: Change from baseline in best corrected visual acuity by ETDRS
Time frame: Baseline, Month 9
Mean change from Baseline at Day 270 (Month 9) in best corrected visual acuity (BCVA) measured by early treatment diabetic retinopathy (ETDRS)
17 secondary outcomes
Phase 1: Change from baseline in BCVA by ETDRS
Time frame: 8 months
Phase 1: Change from baseline in sub-retinal thickness
Time frame: 8 months
Phase 1: Change from baseline in retinal fluid by SD-OCT
Time frame: 8 months
Phase 1: Change from baseline in total lesion area by FA/CFP
Time frame: 8 months
Phase 1: Change from baseline in CNV lesion area by FA/CFP
Time frame: 8 months
Phase 1: Change from baseline in fluorescein leakage area by FA/CFP
Time frame: 8 months
Phase 1: Rescue medication
Time frame: 8 months
Phase 1: Systemic exposure to sunitinib measured in plasma level
Time frame: 8 months
Phase 1: Change from baseline in sub retinal hyper reflective material (SHRM) height
Time frame: 8 months
Phase 2: Proportion of subjects with absence of retinal fluid by SD-OCT
Time frame: 12 months
Phase 2: Proportion of subjects with < 15 BCVA letter loss by ETDRS
Time frame: 12 months
Phase 2: Proportion of subjects with ≥ 15 BCVA letters gained by ETDRS
Time frame: 12 months
Phase 2: Occurrence of ocular and nonocular adverse events (AEs)
Time frame: 12 months
Phase 2: Change from baseline in BCVA by ETDRS
Time frame: 12 months
Phase 2: Systemic exposure to sunitinib measured in plasma level
Time frame: 12 months
Phase 2: Change from baseline in sub-retinal thickness
Time frame: 12 months
Phase 2: Rescue medication
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2019.
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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.
Charles P. Semba, MD study director
Graybug Vision, Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GB-102 and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Graybug Vision at 8 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 3 inclusion and 5 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 20 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Phase 1: Occurrence of ocular and nonocular adverse events (AEs) (time frame: 8 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Dec 2019.