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Age-Related Macular DegenerationPhase 2NCT02387957

A 24 Month Phase 2a Open Label, Randomized Study of Avastin®, Lucentis®, or Eylea® (Anti-VEGF Therapy) Administered in Combination With Fovista® (Anti-PDGF BB Pegylated Aptamer)

A Phase 2 study testing Fovista®, bevacizumab and ranibizumab in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 24 sites in United States.

Terminated

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

Official record
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Trial summary

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Fovista®, bevacizumab and ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
24 sitesUnited States
Study dates
26 Apr 2016to Jan 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

  • Subjects of either gender aged ≥ 50 years.
  • Active subfoveal choroidal neovascularization (CNV) due to AMD.

Who cannot join

  • Any intraocular surgery or thermal laser within three (3) months of trial entry. Any prior thermal laser in the macular region, regardless of indication.
  • Subjects with subfoveal scar or subfoveal atrophy
  • Any ocular or periocular infection in the past twelve (12) weeks.
  • History of any of the following conditions or procedures in the study eye: Rhegmatogenous retinal detachment, pars plana vitrectomy, filtering surgery (e.g. trabeculectomy), glaucoma drainage device, corneal transplant.

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Study site

    Abilene, Texas, 85014

  • Study site

    Amarillo, Texas, 79106

  • Study site

    Augusta, Georgia, 30909

  • Study site

    Beverly Hills, California, 90211

  • Study site

    Boston, Massachusetts, 02114

  • Study site

    Cleveland, Ohio, 44130

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Huntingdon Valley, Pennsylvania, 19006

  • Study site

    Ladson, South Carolina, 29456

  • Study site

    Minneapolis, Minnesota, 55435

  • Study site

    Morgantown, West Virginia, 26506

  • Study site

    New London, Connecticut, 06320

  • Study site

    Oak Forest, Illinois, 60452

  • Study site

    Phoenix, Arizona, 85014

  • Study site

    Reno, Nevada, 89502

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95819

  • Study site

    San Antonio, Texas, 78240

  • Study site

    Santa Ana, California, 92705

  • Study site

    Silverdale, Washington, 98383

  • Study site

    Southfield, Michigan, 48034

  • Study site

    The Woodlands, Texas, 77384

  • Study site

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

To evaluate the safety of intravitreal (IVT) Fovista® administered in combination with anti-VEGF therapy.

Read the detailed description

60 subjects randomized 1:1:1 and treated with IVT Fovista® 1.5 mg/eye in combination with anti-VEGF therapy as follows:

  • Avastin® 1.25 mg/eye (20 subjects)
  • Lucentis® 0.5 mg/eye (20 subjects)
  • Eylea® 2.0 mg/eye (20 subjects)

Subjects will be stratified by lesion size (≤2 DA vs. >2 DA).

Subjects will be treated with "combination therapy" of IVT Fovista® and IVT anti-VEGF therapy every month for the first 5 months (Day 1, Months 1,2,3,4), followed by Q12W (every 12 weeks) administration (Months 7,10, 13,16, 19 and 22), for a total of 24 months.

When administered, IVT Fovista® will be given first, followed by IVT anti-VEGF (same day).

Being tested
Fovista®, bevacizumab, ranibizumab, aflibercept
Keywords
Wet AMD, subfoveal choroidal neovascularization, Fovista®, Avastin®, Lucentis®, Eylea®
Medical subject headings
Macular Degeneration

What participants receive

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

  • Fovista®Drug

  • bevacizumabDrug

    Also called Avastin®

  • ranibizumabDrug

    Also called Lucentis®

  • afliberceptDrug

    Also called Eylea®

Study groups in NCT02387957
Study groupRoleWhat they receive
Fovista® plus bevacizumabExperimentalFovista® 1.5 mg intravitreal injection + bevacizumab 1.25 mg intravitreal injection
Receives: Drug: Fovista®; Drug: bevacizumab
Fovista® plus ranibizumabExperimentalFovista® 1.5 mg intravitreal injection + 0.5 mg ranibizumab intravitreal injection
Receives: Drug: Fovista®; Drug: ranibizumab
Fovista® plus afliberceptExperimentalFovista® 1.5 mg intravitreal injection + 2.0 mg aflibercept intravitreal injection
Receives: Drug: Fovista®; Drug: aflibercept

What is being measured

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

  1. Total Numer of Systemic Adverse Events

    Number of Patients with Systemic Adverse Events

    Measured: 2 years

  2. Total Number of Other Adverse Events (>5%)

    Number of Patients with Other Adverse Events

    Measured: 2 years

Timeline

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

  1. First posted13 Mar 2015 (estimated)
  2. Study start26 Apr 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

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
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02387957
Sponsor's protocol ID
OPH1006
Status last verified
Feb 2019
First submitted
9 Mar 2015
Last updated
30 Oct 2024
Data monitoring committee
No
Individual data sharing
No: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Fovista®, bevacizumab and ranibizumab in people with Age-Related Macular Degeneration, run by Ophthotech Corporation at 24 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 2 inclusion and 4 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 30 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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 5 Mar 2019). 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?

Total Numer of Systemic Adverse Events (time frame: 2 years). 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?

On the ClinicalTrials.gov record for NCT02387957.

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 30 Oct 2024.

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