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Neovascular Age-Related Macular DegenerationPhase 2CAPELLANCT02418754

Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

A Phase 2 study testing REGN2176-3 and Intravitreal Aflibercept Injection (IAI) in people with Neovascular Age-Related Macular Degeneration, run by Regeneron Pharmaceuticals at 84 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
REGN2176-3 and Intravitreal Aflibercept Injection (IAI)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
505 participants
Where
84 sitesin 2 countries
Study dates
5 May 2015to 3 Apr 2017
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

  • Men or women ≥50 years of age
  • Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as determined by the reading center, including juxtafoveal lesions that affect the fovea
  • BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the screening visit
  • Provide signed informed consent

Who cannot join

  • Any prior treatment with anti-VEGF treatment in the study eye
  • Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors
  • Dense fibrotic scar or atrophy in the study eye involving the center of the fovea
  • Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
  • Prior vitrectomy in the study eye
  • Any history of macular hole of stage 2 and above in the study eye
Show all 10Show fewer
  • Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
  • History of corneal transplant in the study eye
  • Evidence of diabetic retinopathy or diabetic macular edema in either eye
  • Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or baseline visit

Trial locations and contacts

84 sites in 2 countries.

84 sites in 2 countries

United States75 sites

  • Study site

    Abilene, Texas

  • Study site

    Albany, New York

  • Study site

    Albuquerque, New Mexico

  • Study site

    Arcadia, California

  • Study site

    Asheville, North Carolina

  • Study site

    Augusta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Bellevue, Washington

  • Study site

    Beverly Hills, California

  • Study site

    Bloomfield, New Jersey

  • Study site

    Boston, Massachusetts

  • Study site

    Burlington, Vermont

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Colorado Springs, Colorado

  • Study site

    Dallas, Texas

  • Study site

    East Setauket, New York

  • Study site

    Fairfax, Virginia

  • Study site

    Florence, South Carolina

  • Study site

    Florissant, Missouri

  • Study site

    Fort Lauderdale, Florida

  • Study site

    Fort Myers, Florida

  • Study site

    Fort Worth, Texas

  • Study site

    Great Neck, New York

  • Study site

    Houston, Texas

  • Study site

    Iowa City, Iowa

  • Study site

    Irvine, California

  • Study site

    Jackson, Michigan

  • Study site

    Jacksonville, Florida

  • Study site

    Kingston, Pennsylvania

  • Study site

    Knoxville, Tennessee

  • Study site

    Ladson, South Carolina

  • Study site

    Las Vegas, Nevada

  • Study site

    Lexington, Kentucky

  • Study site

    Lincoln, Nebraska

  • Study site

    Marietta, Georgia

  • Study site

    McAllen, Texas

  • Study site

    Melbourne, Florida

  • Study site

    Memphis, Tennessee

  • Study site

    Miami, Florida

  • Study site

    Minneapolis, Minnesota

  • Study site

    Monroeville, Pennsylvania

  • Study site

    Mountain View, California

  • Study site

    Nashville, Tennessee

  • Study site

    New Brunswick, New Jersey

  • Study site

    New York, New York

  • Study site

    Oak Forest, Illinois

  • Study site

    Oceanside, California

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orchard Park, New York

  • Study site

    Paducah, Kentucky

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Plantation, Florida

  • Study site

    Portland, Oregon

  • Study site

    Rapid City, South Dakota

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Salt Lake City, Utah

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Shawnee Mission, Kansas

  • Study site

    Southfield, Michigan

  • Study site

    Springfield, Illinois

  • Study site

    Tampa, Florida

  • Study site

    The Woodlands, Texas

  • Study site

    Towson, Maryland

  • Study site

    Tucson, Arizona

  • Study site

    Urbana, Illinois

  • Study site

    West Columbia, South Carolina

  • Study site

    Willow Park, Texas

  • Study site

    Winter Haven, Florida

Other trials in United States

Japan9 sites

  • Study site

    Akita

  • Study site

    Asahikawa

  • Study site

    Chiyoda-ku

  • Study site

    Fukushima

  • Study site

    Kawasaki

  • Study site

    Matsumoto

  • Study site

    Nagasaki

  • Study site

    Nagoya

  • Study site

    Osaka

Other trials in Japan

About this study

Official title: A Phase 2, Double-Masked, Randomized, Controlled, Multiple-Dose, Regimen-Ranging Study of the Efficacy and Safety of Intravitreal REGN2176-3 in Patients With Neovascular Age-Related Macular Degeneration

The primary objective of the study was to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in participants with neovascular age-related macular degeneration (AMD), compared to intravitreal aflibercept injection (IAI) monotherapy.

The secondary objectives of the study were the following:

  • To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in participants with nAMD compared to IAI monotherapy (at week 12)
  • To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered the same or additional benefit compared to continuous treatment with REGN2176-3. Also to determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared to continuous treatment with IAI.
  • To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD
Being tested
REGN2176-3, Intravitreal Aflibercept Injection (IAI)

What participants receive

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

  • REGN2176-3Drug

  • Intravitreal Aflibercept Injection (IAI)Drug

    Also called Eylea®

Study groups in NCT02418754
Study groupRoleWhat they receive
REGN2176-3 (1 mg: 2 mg)ExperimentalIntravitreal injection of REGN2176-3 (REGN2176 1 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Receives: Drug: REGN2176-3
REGN2176-3 (3 mg: 2 mg)ExperimentalIntravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Receives: Drug: REGN2176-3
Intravitreal Aflibercept Injection (IAI) 2 mgExperimentalIAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly up to Week 28, then criteria based re-dosing from Week 28-52.
Receives: Drug: Intravitreal Aflibercept Injection (IAI)
REGN2176-3 (3 mg: 2 mg) to IAI 2 mgExperimentalIntravitreal injection of REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) every 4 weeks for 12 weeks. After Week 12, dosing was monthly with IAI 2 mg up to Week 28, then criteria based re-dosing from Week 28-52.
Receives: Drug: Intravitreal Aflibercept Injection (IAI)
IAI 2 mg to REGN2176-3 (3 mg:2 mg)ExperimentalIAI every 4 weeks for 12 weeks. After Week 12, dosing was monthly with REGN2176-3 (REGN2176 3 mg and REGN3 2 mg) up to Week 28, then criteria based re-dosing from Week 28-52.
Receives: Drug: REGN2176-3

What is being measured

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

  1. Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12

    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Change from baseline calculated by subtracting baseline value from observed post-baseline value at Week 12.

    Measured: Baseline, Week 12

Secondary outcomes (7)

  1. Change From Baseline in Central Subfield Retinal Thickness (CST) at Week 12, as Measured by Optical Coherence Tomography (OCT)

    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.

    Measured: Baseline, Week 12

  2. Percentage of Participants With Complete Resolution of Intraretinal and Subretinal Fluid From Baseline at Week 12 Measured by Optical Coherence Tomography (OCT)

    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation.

    Measured: Week 12

  3. Change From Baseline in Choroidal Neovascularization (CNV) Area at Week 12 Measured by Fluorescein Angiography (FA)

    The anatomical state of the retinal vasculature of the study eye and the fellow eye was evaluated by funduscopic examination, fundus photography and FA to evaluate the total lesion area, CNV area, classic CNV area, and fluorescein leakage. CNV area values measured in square millimeters, each disc area was equivalent to 2.54 mm^2 on the retina; lower values represent better outcomes.

    Measured: Baseline, Week 12

  4. Change From Baseline in Total Lesion Size at Week 12 Measured by Fluorescein Angiography (FA)

    Total Lesion Size was assessed by Fluorescein Angiography.

    Measured: Baseline, Week 12

  5. Percentage of Participants Who Gained At Least 15 Letters in BCVA From Baseline at Week 12, Measured by 4-meter Early Treatment Diabetic Retinopathy Scale (ETDRS)

    Visual function of the study eye was assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at 4 meters. BCVA score was measured using an eye chart and was reported as the number of letters read correctly at a testing distance of 4 meters using the ETDRS Scale (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. This outcome assessed the percentage of participants who gained 15 or more letters of visual acuity at Week 12 compared with baseline.

    Measured: Week 12

  6. Percent Change From Baseline in Subretinal Hyperreflectivity Material (SHM) at Week 12 Measured by Optical Coherence Tomography (OCT)

    SHM was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement.

    Measured: Baseline, Week 12

  7. Change From Baseline in Central Retinal/Lesion Thickness at Week 12 Measured by Optical Coherence Tomography (OCT)

    CST was assessed using spectral domain optical coherence tomography (SD-OCT), a non-invasive diagnostic system providing high-resolution imaging sections of the retina. SD-OCT was performed in the study eye after pupil dilation. A negative change from baseline indicated improvement. Change from baseline calculated by subtracting baseline value from LOCF post-baseline value at Week 12.

    Measured: Baseline, Week 12

Timeline

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

  1. First posted16 Apr 2015 (estimated)
  2. Study start5 May 2015
  3. Primary completion17 Aug 2016
  4. Study completion3 Apr 2017

Why it stopped: No additional efficacy seen with REGN2176-3 over aflibercept alone

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02418754
Sponsor's protocol ID
R2176-3-AMD-1417
Acronym
CAPELLA
Status last verified
Oct 2020
First submitted
13 Apr 2015
Last updated
26 Oct 2020
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 REGN2176-3 and Intravitreal Aflibercept Injection (IAI) in people with Neovascular Age-Related Macular Degeneration, run by Regeneron Pharmaceuticals at 84 sites in 2 countries.

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 10 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: stopped early, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 84 sites in United States, Japan. 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 26 Oct 2020). 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?

Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye at Week 12 (time frame: Baseline, Week 12). 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 NCT02418754.

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 26 Oct 2020.

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