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Completed

NCT Number: NCT03953079

A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD

Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels of GB-102 compared with aflibercept.

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Key information

Conditions

Neovascular Age-related Macular Degeneration Choroid Diseases Choroidal Neovascularization Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Retinal Consultants AZ, Gilbert, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males or females ≥ 50 years of age
  • Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • Best-corrected visual acuity (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 intraocular pressure (IOP)
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating

Treatment and study plan

Drug: GB-102

Drug

Intravitreal injection of GB-102

Other names: Sunitinib malate

aflibercept

Drug

Intravitreal injection of aflibercept (2 mg dose)

Other names: Eylea

Primary outcomes

  1. Time to First Rescue Treatment

    Time frame: Baseline through 12 months

    Kaplan-Meier estimate of the median time to first rescue treatment.

Secondary outcomes

  1. 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

  2. Number of Times That at Least One Rescue Criterion is Met

    Time frame: Baseline through 12 months

    Assessment of the number of monthly intervals that at least one rescue criterion is met

  3. 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

  4. Change From Baseline in Best-corrected Visual Acuity (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

  5. 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

  6. 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.

  7. Change From Baseline in Central Subfield Thickness (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

  8. 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

Sponsors and collaborators

Lead sponsor

Graybug Vision

Industry

Registry information

Official study 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)

Acronym: ALTISSIMO

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
May 16, 2019
Registry last updated
Jan 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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