Age-related Macular DegenerationPhase 2NCT02214628
Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF BB) Regimen Administered in Combination With Anti-VEGF Therapy to Study Sub-Retinal Fibrosis in Neovascular AMD
A Phase 2 study testing Fovista® (anti-PDGF BB) plus anti-VEGF in people with Age-related Macular Degeneration, run by Ophthotech Corporation at 13 sites in United States.
Trial summary
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) 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® (anti-PDGF BB) plus anti-VEGF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 13 sitesUnited States
- Study dates
- Jul 2014to Dec 2016
- 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
- All fluorescein angiographic subtypes with presence of active choroidal neovascularization
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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Study site
Abilene, Texas, 79606
Study site
Augusta, Georgia, 30909
Study site
Beverly Hills, California, 90211
Study site
Boston, Massachusetts, 02114
Study site
Cincinnati, Ohio, 45242
Study site
Jackson, Michigan, 49202
Study site
Ladson, South Carolina, 29456
Study site
Minneapolis, Minnesota, 55435
Study site
Oak Forest, Illinois, 60452
Study site
Phoenix, Arizona, 85014
Study site
Sacramento, California, 95819
Study site
Sacramento, California, 95841
Study site
Santa Ana, California, 92705
About this study
Official title: A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
Read the detailed description
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).
- Conditions
- Age-related Macular Degeneration
- Being tested
- Fovista® (anti-PDGF BB) plus anti-VEGF
- Keywords
- Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®
- 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.
Fovista® (anti-PDGF BB) plus anti-VEGFDrug
Also called Fovista®, anti-VEGF
| Study group | Role | What they receive |
|---|---|---|
| Fovista® plus anti-VEGF Simultaneous | Experimental | Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. Receives: Drug: Fovista® (anti-PDGF BB) plus anti-VEGF |
| Fovista® plus anti-VEGF Pre-Treatment | Experimental | Subjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration. Receives: Drug: Fovista® (anti-PDGF BB) plus anti-VEGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)
Measured: 2 years
Number of Subjects With Serious Adverse Events
Number of subjects with serious adverse events in each arm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ophthotech Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214628
- Sponsor's protocol ID
- OPH1005
- Status last verified
- Jan 2019
- First submitted
- 5 Aug 2014
- Last updated
- 23 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Month Phase 2A Open Label Safety Study of Fovista® (Anti-PDGF-BB Pegylated Aptamer) Regiment Administered in Combination With Avastin®, Eylea®, or Lucentis®) During the Induction and Maintenance Phase of Therapy
- ClinicalTrials.gov ID
- NCT02214628
- Acronym / sponsor ID
- OPH1005
- Conditions
- Age-related Macular Degeneration
- Keywords
- Wet AMD, Choroidal neovascularization, Fovista®, E10030, Avastin®, Eylea®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Ophthotech CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Posted 10 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy.
Detailed description
The objective is to evaluate the safety of intravitreal Fovista® (anti-PDGF BB) administered in combination with anti-VEGF therapy in either a "Simultaneous" Regimen (Fovista® administered with anti-VEGF same day) or "Pre-Treatment" Regimen (monotherapy Fovista® Day 0 followed by Fovista® administered in combination with anti-VEGF Day 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fovista® plus anti-VEGF Simultaneous | Experimental | Drug: Fovista® (anti-PDGF BB) plus anti-VEGFSubjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Simultaneous" regimen followed by quarterly administration. |
| Fovista® plus anti-VEGF Pre-Treatment | Experimental | Drug: Fovista® (anti-PDGF BB) plus anti-VEGFSubjects will be administered Fovista® (anti-PDGF BB) plus anti-VEGF as a "Pre-Treatment" regimen followed by quarterly administration. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects of either gender aged ≥ 50 years
- All fluorescein angiographic subtypes with presence of active choroidal neovascularization
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fovista® (anti-PDGF BB) plus anti-VEGFAlso: Fovista®, anti-VEGF | Drug | Fovista® plus anti-VEGF Pre-Treatment, Fovista® plus anti-VEGF Simultaneous |
Primary outcome
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects)
Time frame: 2 years
Number of subjects on either arm with non-serious adverse events (reported by >5% of subjects)
Number of Subjects With Serious Adverse Events
Time frame: 2 years
Number of subjects with serious adverse events in each arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fovista® (anti-PDGF BB) plus anti-VEGF in people with Age-related Macular Degeneration, run by Ophthotech Corporation at 13 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 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 10 Jul 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?
Number of Subject With Non Serious Adverse Events (Reported by >5% of Subjects) (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?
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 23 Feb 2024.