A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD (ALTISSIMO)
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| ClinicalTrials.gov Identifier: NCT03953079 |
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Recruitment Status :
Completed
First Posted : May 16, 2019
Last Update Posted : July 15, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neovascular Age-Related Macular Degeneration | Drug: Drug: GB-102 Drug: Aflibercept | Phase 2 |
Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of the effect of GB-102, as measured by time to first rescue treatment across multiple dose levels of GB-102 administered every 6 months as compared to intravitreal (IVT) aflibercept administered every 2 months in subjects with neovascular (wet) age-related macular degeneration who have received prior induction with anti-vascular endothelial growth factor (VEGF)
Extension Study:
To monitor the safety and duration of effect of IVT GB-102 administered every 6 months compared to IVT aflibercept administered every 2 months in subjects in ALTISSIMO (Core Study) who complete all study visits through Month 12 (Day 360) and who do not require/receive rescue treatment at the Month 12 (Day 360) final study visit
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 56 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel-arm design |
| Masking: | Single (Outcomes Assessor) |
| Masking Description: | Visual examiner-masked |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2b Multicenter Dose-Ranging Study Evaluating the Safety and Efficacy of Sunitinib Malate Depot Formulation (GB-102) Compared to Aflibercept in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALTISSIMO Study) |
| Actual Study Start Date : | September 26, 2019 |
| Actual Primary Completion Date : | December 15, 2020 |
| Actual Study Completion Date : | June 3, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: GB-102 Dose 2 (1 mg)
Participants will receive intravitreal (IVT) GB-102 (1 mg) in the study eye at Baseline and Month 6 and sham at Months 2, 4, 8 and 10.
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Drug: Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate |
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Experimental: GB-102 Dose 3 (2 mg)
Participants will receive intravitreal (IVT) GB-102 (2 mg) in the study eye at Baseline, intravitreal (IVT) GB-102 (1 mg) at Month 6 and sham at Months 2, 4, 8 and 10.
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Drug: Drug: GB-102
Intravitreal injection of GB-102
Other Name: Sunitinib malate |
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Active Comparator: Aflibercept 2 mg Dose
Participants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
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Drug: Aflibercept
Intravitreal injection of aflibercept (2 mg dose)
Other Name: Eylea |
- Kaplan-Meier analysis of time to first rescue treatment [ Time Frame: Baseline through 12 months ]
- Time to fulfillment of at least one rescue criterion [ Time Frame: 6 months through 12 months ]Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit
- Number of times that at least one rescue criterion is met [ Time Frame: Baseline through 12 months ]Assessment of the number of times that at least one rescue criterion is met
- Number of treatments, including both rescue and scheduled study treatments, during the study [ Time Frame: Baseline through 12 months ]Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study
- Change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy
BCVA ETDRS range = 0 (worst) to 100 (best)
Assessment of change in BCVA (ETDRS letter score) from baseline at all visits
- Categorical change from baseline in BCVA (ETDRS letter score) at all visits [ Time Frame: Baseline through 12 months ]
BCVA = best corrected visual acuity; ETDRS = early treatment of diabetic retinopathy
BCVA ETDRS range = 0 (worst) to 100 (best)
Assessment of categorical change in BCVA (ETDRS letter score) from baseline at all visits
- Frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits [ Time Frame: Baseline through 12 months ]
Assessment of the frequency of subjects with BCVA worse than 20/200 (Snellen equivalent) at all visits
A vision score of 20/20 is considered normal. A vision score of 20/200 is considered legally blind.
- Change from baseline in CST (μm) at all visits [ Time Frame: Baseline through 12 months ]
CST = central subfield thickness
Assessment of change in CST (μm) measurement from baseline at all visits
- Frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at at all visits [ Time Frame: Baseline through 12 months ]Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits
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| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males or females ≥ 50 years of age
- Presence of a CNV lesion secondary to AMD 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 35 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
- Abnormal liver function
- Women who are pregnant or lactating
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953079
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| Study Director: | Chief Medical Officer | Graybug Vision, Inc. |
| Responsible Party: | Graybug Vision |
| ClinicalTrials.gov Identifier: | NCT03953079 |
| Other Study ID Numbers: |
GBV-102-002 |
| First Posted: | May 16, 2019 Key Record Dates |
| Last Update Posted: | July 15, 2021 |
| Last Verified: | May 2021 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Age-related macular degeneration Choroidal neovascularization |
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Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Sunitinib Aflibercept Antineoplastic Agents Angiogenesis Inhibitors |
Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |