Neovascular Age Related Macular DegenerationPhase 1NCT00383370
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
A Phase 1 study testing VEGF Trap in people with Neovascular Age Related Macular Degeneration, run by Regeneron Pharmaceuticals at 6 sites in United States.
Trial summary
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Neovascular Age Related Macular Degeneration
- What is being tested?
- VEGF Trap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2006to Jul 2008
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
Who cannot join
- No prior treatment with the following in the study eye:
- Subfoveal thermal laser therapy;
- Submacular surgery or other surgical intervention for the treatment of AMD;
- Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1 (Visit 2);
- PDT or ITV administration of triamcinolone acetonide or any other steroid within 12 weeks prior to Day 1 (Visit 2);
- Pegaptanib sodium within 8 weeks of Day 1 (Visit 2);
Show all 13Show fewer
- Juxtascleral steroids or anecortave acetate within 180 Days (6 months) prior to Day 1 (visit 2);
- Prior systemic or intravitreal treatment with VEGF Trap or bevacizumab;
- Any investigational agent for the treatment of eye disease within 12 weeks of Day 1 (Visit 2)
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Austin, Texas, 78705
Study site
Columbia, South Carolina, 29169
Study site
Fort Myers, Florida, 33907
Study site
Hagerstown, Maryland, 21740
Study site
McAllen, Texas, 78503
Study site
Wichita, Kansas, 67214
About this study
Official title: A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Read the detailed description
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
- Being tested
- VEGF Trap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEGF TrapDrug
Also called ITV-1
VEGF Trap formulation 1, ITV-1
VEGF TrapBiological
Also called ITV-2
VEGF Trap formulation 2 at higher concentration in Open label cohort
| Study group | Role | What they receive |
|---|---|---|
| ITV-1 | Experimental | VEGF Trap formulation 1 Receives: Drug: VEGF Trap |
| ITV-2 | Experimental | VEGF Trap formulation 2 Receives: Drug: VEGF Trap |
| ITV-2 OL | Experimental | VEGF Trap formulation 2 open label, higher concentration Receives: Biological: VEGF Trap |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2006 (estimated)
- Study startOct 2006
- Primary completionSep 2007
- Study completionJul 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Avner Ingerman, MD, Study director, Regeneron Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00383370
- Sponsor's protocol ID
- VGFT-OD-0603
- Status last verified
- Apr 2011
- First submitted
- 2 Oct 2006
- Last updated
- 21 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Assess the Safety and Tolerability of Repeated Doses of Intravitreal Administration of Two VEGF Trap Formulations in Subjects With Neovascular Age Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00383370
- Acronym / sponsor ID
- VGFT-OD-0603
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Oct 2006 (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.
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Detailed description
A double-masked study in which approximately 12 subjects will receive ITV injections of VEGF Trap every 4 weeks for a total of 3 doses. Once the subjects have received the 3 doses allowed in this study, they will be evaluated every 4 weeks for continued dosing of VEGF Trap for an additional 9 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ITV-1 | Experimental | Drug: VEGF TrapVEGF Trap formulation 1 |
| ITV-2 | Experimental | Drug: VEGF TrapVEGF Trap formulation 2 |
| ITV-2 OL | Experimental | Biological: VEGF TrapVEGF Trap formulation 2 open label, higher concentration |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subfoveal CNV secondary to AMD.
- Central retinal (including lesion) thickness ≥ 250 µm as measured by OCT.
- ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/400 (73 to 20 letters)
Key exclusion criteria (13 listed)
- No prior treatment with the following in the study eye:
- History of any vitreous hemorrhage within 4 weeks prior to baseline injection visit.
- Aphakia or pseudophakia with the absence of a posterior capsule (unless it occurred as a result of a yttrium aluminum garnet [YAG] capsulotomy).
- Significant subfoveal atrophy or scarring.
- Any condition or laboratory abnormality that, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the subject's appropriate participation in this study
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 |
|---|---|---|
| VEGF TrapAlso: ITV-1VEGF Trap formulation 1, ITV-1 | Drug | ITV-1, ITV-2 |
| VEGF TrapAlso: ITV-2VEGF Trap formulation 2 at higher concentration in Open label cohort | Biological | ITV-2 OL |
Primary outcome
The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs.
Time frame: 12 weeks
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 21 Apr 2011.
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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.
Avner Ingerman, MD study director
Regeneron Pharmaceutical
6 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 VEGF Trap in people with Neovascular Age Related Macular Degeneration, run by Regeneron Pharmaceuticals at 6 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 3 inclusion and 13 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 21 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The primary endpoint of the study will be safety and tolerability of the study treatment at Week 12 as assessed by ophthalmic examination and reporting of AEs. (time frame: 12 weeks). 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 21 Apr 2011.