Neovascular Age-Related Macular DegenerationPhase 1NCT01997164
Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)
A Phase 1 study testing REGN910-3, REGN910 and Intravitreal Aflibercept Injection (IAI) in people with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 5 sites in United States.
Trial summary
The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
- What is being tested?
- REGN910-3, REGN910 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
- 20 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2014to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For patients with AMD:
- Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator
- Men or women ≥50 years and older
- For patients with DME:
- Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
- Men or women ≥18 years and older
Who cannot join
- For patients with neovascular AMD:
- Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
- Evidence of diabetic retinopathy (DR) or DME in either eye
- For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
- Prior IAI in either eye
- IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
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- Any prior treatment with angiopoietin inhibitors
- Any prior systemic (IV) anti-VEGF administration
- History of vitreoretinal surgery in the study eye
- Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
- Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening
- (The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Study site
Abilene, Texas
Study site
Beverly Hills, California
Study site
Boston, Massachusetts
Study site
West Columbia, South Carolina
Study site
Winter Haven, Florida
About this study
Official title: An Open-Label, Dose-Escalation Study of the Safety and Tolerability of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular AMD or DME
The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).
- Being tested
- REGN910-3, REGN910, Intravitreal Aflibercept Injection (IAI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN910-3Drug
REGN910Drug
Intravitreal Aflibercept Injection (IAI)Drug
Also called EYLEA®
| Study group | Role | What they receive |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI Receives: Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI) |
| Cohort 5 | Experimental | Participants in cohort 5 will receive IVT REGN910 and IAI Receives: Drug: REGN910; Drug: Intravitreal Aflibercept Injection (IAI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events (TEAEs)
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
Measured: Change from baseline to week 24
Secondary outcomes (2)
Pharmacokinetic (PK) profile
PK profile may include, but is not limited to, the following:
- AUCall - area under the curve (AUC) computed from time zero to the time of the last concentration
- AUCall/Dose - AUCall-to-dose ratio
- AUClast - AUC computed from time zero to the time of the last positive concentration
- AUClast/Dose - AUClast-to-dose ratio
- Cmax - the peak concentration
- Cmax/Dose - Cmax-to-dose ratio
Measured: Baseline to week 24
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997164
- Sponsor's protocol ID
- R910-3-OD-1403
- Status last verified
- Jan 2016
- First submitted
- 22 Nov 2013
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Dose-Escalation Study of the Safety and Tolerability of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular AMD or DME
- ClinicalTrials.gov ID
- NCT01997164
- Acronym / sponsor ID
- R910-3-OD-1403
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohorts 1 through 4 | Experimental | Drug: REGN910-3, Drug: Intravitreal Aflibercept Injection (IAI)Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI |
| Cohort 5 | Experimental | Drug: REGN910, Drug: Intravitreal Aflibercept Injection (IAI)Participants in cohort 5 will receive IVT REGN910 and IAI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- For patients with AMD:
- For patients with DME:
Key exclusion criteria (12 listed)
- For patients with neovascular AMD:
- For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
- Prior IAI in either eye
- IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
- Any prior treatment with angiopoietin inhibitors
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 |
|---|---|---|
| REGN910-3 | Drug | Cohorts 1 through 4 |
| REGN910 | Drug | Cohort 5 |
| Intravitreal Aflibercept Injection (IAI)Also: EYLEA® | Drug | Cohort 5, Cohorts 1 through 4 |
Primary outcome
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: Change from baseline to week 24
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
2 secondary outcomes
Pharmacokinetic (PK) profile
Time frame: Baseline to week 24
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Time frame: Baseline to week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
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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.
Clinical Trial Management study director
Regeneron Pharmaceuticals
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN910-3, REGN910 and Intravitreal Aflibercept Injection (IAI) in people with Neovascular Age-Related Macular Degeneration and Diabetic Macular Edema, run by Regeneron Pharmaceuticals at 5 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 6 inclusion and 12 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 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of treatment-emergent adverse events (TEAEs) (time frame: Change from baseline to week 24). 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 12 Jan 2016.