AzTrials
AzTrials

Neovascular Age-Related Macular DegenerationPhase 2ALTISSIMONCT03953079

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

A Phase 2 study testing Drug: GB-102 and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Graybug Vision at 33 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Drug: GB-102 and Aflibercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
33 sitesUnited States
Study dates
26 Sep 2019to 3 Jun 2021
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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

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 intraocular pressure (IOP)
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating

Trial locations and contacts

33 sites in 1 country.

33 sites in 1 country

United States33 sites

  • Retina Consultants of Hawaii

    ‘Aiea, Hawaii, 96701

  • Retina Research Institute of Texas

    Abilene, Texas, 79606

  • Southeast Retina Center

    Augusta, Georgia, 30909

  • Austin Retina Associates

    Austin, Texas, 78705

  • Retina Research Center, PLLC

    Austin, Texas, 78705

  • California Retina Research Consultants

    Bakersfield, California, 93309

  • Retinal Diagnostic Center of Northern California

    Campbell, California, 95008

  • Sterling Research

    Cincinnati, Ohio, 45219

  • Specialty Retina Center

    Coral Springs, Florida, 32503

  • Wolfe Eye Clinic - West Des Moines

    Des Moines, Iowa, 50266

  • The Retina Partners

    Encino, California, 91436

  • Retina Consultants of Orange County

    Fullerton, California, 92835

  • Retinal Consultants AZ

    Gilbert, Arizona, 85296

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland, 21740

  • University Retina and Macula

    Lemont, Illinois, 60439

  • Piedmont Eye Center

    Lynchburg, Virginia, 24502

  • Northern California Retina Vitreous Associates Medical Group, Inc.

    Mountain View, California, 94040

  • Ophthalmic Consultants of Long Island

    Oceanside, New York, 11572

  • Florida Retina Institute

    Orlando, Florida, 32806-1101

  • Retina Specialty Institute

    Pensacola, Florida, 32503

  • Retinal Research Institute

    Phoenix, Arizona, 85017

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782

  • Retina Specialists

    Plano, Texas, 75093

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

  • Sierra Eye Associates

    Reno, Nevada, 89502

  • West Coast Retina Medical Group, Inc.

    San Francisco, California, 94109

  • California Retina Consultants - CRC

    Santa Barbara, California, 93103

  • Retina Center NW PLLC

    Silverdale, Washington, 98383

  • Retina Consultants of Houston

    The Woodlands, Texas, 77384

  • Bay Area Retina Associates

    Walnut Creek, California, 94598

  • Eye Associates of Northeast Louisiana

    West Monroe, Louisiana, 71291

  • Strategic Clinical Research Group LLC

    Willow Park, Texas, 76087

Other trials in United States

About this study

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)

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.

Read the detailed description

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

Being tested
Drug: GB-102, Aflibercept
Keywords
Age-related macular degeneration (AMD), 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.

  • Drug: GB-102Drug

    Also called Sunitinib malate

    Intravitreal injection of GB-102

  • AfliberceptDrug

    Also called Eylea

    Intravitreal injection of aflibercept (2 mg dose)

Study groups in NCT03953079
Study groupRoleWhat they receive
GB-102 1 mg/1 mgExperimentalParticipants 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.
Receives: Drug: Drug: GB-102
GB-102 2 mg/1 mgExperimentalParticipants 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.
Receives: Drug: Drug: GB-102
Aflibercept 2 mgActive comparatorParticipants will receive intravitreal (IVT) aflibercept 2 mg in the study eye at Baseline, Months 2, 4, 6, 8 and 10.
Receives: Drug: Aflibercept

What is being measured

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

  1. Time to First Rescue Treatment

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

    Measured: Baseline through 12 months

Secondary outcomes (8)

  1. Time to Fulfillment of at Least One Rescue Criterion

    Assessment of time to fulfillment of at least one rescue criterion starting at the Month 6 visit through to the Month 12 visit

    Measured: 6 months through 12 months

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

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

    Measured: Baseline through 12 months

  3. Number of Treatments, Including Both Rescue and Scheduled Study Treatments, During the Study

    Assessment of the number of treatments, including both rescue and scheduled study treatments, that occurred during the study

    Measured: Baseline through 12 months

  4. Change From Baseline in Best-corrected Visual Acuity (BCVA) (ETDRS Letter Score) at All Visits

    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

    Measured: Baseline through 12 months

  5. Categorical Change From Baseline in BCVA (ETDRS Letter Score) at All Visits

    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

    Measured: Baseline through 12 months

  6. Frequency of Subjects With BCVA Worse Than 20/200 (Snellen Equivalent) at All Visits

    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.

    Measured: Baseline through 12 months

  7. Change From Baseline in Central Subfield Thickness (CST) (μm) at All Visits

    CST = central subfield thickness

    Assessment of change in CST (μm) measurement from baseline at all visits

    Measured: Baseline through 12 months

  8. Frequency of Subjects With Absence of Exudation (Intra-/Sub-retinal Fluid/Cystoid Edema) at at All Visits

    Assessment of the frequency of subjects with absence of exudation (intra-/sub-retinal fluid/cystoid edema) at all visits

    Measured: Baseline through 12 months

Timeline

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

  1. First posted16 May 2019
  2. Study start26 Sep 2019
  3. Primary completion15 Dec 2020
  4. Study completion3 Jun 2021

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Parallel-arm design
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03953079
Sponsor's protocol ID
GBV-102-002
Acronym
ALTISSIMO
Status last verified
Jan 2022
First submitted
13 May 2019
Last updated
19 Jan 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Drug: GB-102 and Aflibercept in people with Neovascular Age-Related Macular Degeneration, run by Graybug Vision at 33 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 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 19 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 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 11 Jan 2022). 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?

Time to First Rescue Treatment (time frame: Baseline through 12 months). 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 NCT03953079.

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 19 Jan 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in