Macular DegenerationPhase 2NCT00320788

Safety and Efficacy of Repeated Intravitreal Administration of Vascular Endothelial Growth Factor (VEGF) Trap in Patients With Wet Age-Related Macular Degeneration (AMD)

A Phase 2 study testing aflibercept injection (VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Regeneron Pharmaceuticals at 18 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD. The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Macular Degeneration
What is being tested?: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 159 participants
Where: 18 sitesUnited States
Study dates: Apr 2006to Aug 2008
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

Subfoveal CNV secondary to AMD.
Central retinal (including lesion) thickness ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

Who cannot join

History of any vitreous hemorrhage within 4 weeks prior to Day 1.
Aphakia.
Significant subfoveal atrophy or scarring.
Prior treatment with the following in the study eye:
Subfoveal thermal laser therapy.
Submacular surgery or other surgical intervention for the treatment of AMD.

Show all 13Show fewer

Extrafoveal laser coagulation treatment within 12 weeks prior to Day 1.
Photodynamic therapy (PDT) within 12 weeks prior to Visit 2 (Day 1).
Pegaptanib sodium (Macugen) within 8 weeks of Visit 2 (Day 1).
Juxtascleral steroids or anecortave acetate within 24 weeks (6 months) prior to Visit 2 (Day 1).
Intravitreal administration of triamcinolone acetonide or other steroids within 24 weeks prior to Visit 2 (Day 1), unless no visible residue of drug substance can be seen in the vitreous cavity using indirect ophthalmoscopy.
Prior systemic or intravitreal treatment with VEGF Trap, ranibizumab (Lucentis) or bevacizumab (Avastin).
Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II study.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

United States18 sites

Southeast Retina Center
Augusta, Georgia, 30909
Johns Hopkins Hospital School of Medicine
Baltimore, Maryland, 21287
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
Charlotte Eye, Ear, Nose & Throat Asssociates
Charlotte, North Carolina, 28210
University of Chicago
Chicago, Illinois, 60637
Vitreoretinal Consultants Scurlock Tower Texas Medical Center
Houston, Texas, 77030
Midwest Eye Institute
Indianapolis, Indiana, 46280
Loma Linda University Health Care
Loma Linda, California, 92354
Retina-Vitreous Associates, P.C.
Nashville, Tennessee, 37203
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Retina Diagnostic and Treatment Assoc., LLC
Philadelphia, Pennsylvania, 19107
Associated Retina Consultants
Phoenix, Arizona, 85020
Retina Northwest PC
Portland, Oregon, 97210
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
Medical Center Ophthamology
San Antonio, Texas, 78240
Retina Centers, PC
Tucson, Arizona, 85704
New England Retina Consultants PC
West Springfield, Massachusetts, 10189

Other trials in United States

About this study

Official title: A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.

The purpose of this trial is to assess the ocular and systemic safety and tolerability of repeated intravitreal doses of VEGF Trap in patients with subfoveal choroidal neovascularization (CNV) due to AMD.

Read the detailed description

This is a double masked, prospective, randomized study in which five groups of approximately 30 patients meeting the eligibility criteria will be randomly assigned in a balanced ratio to receive a series of intravitreal (IVT) injections of VEGF Trap into the study eye at 4- or 12 -week intervals over a 12-week period.

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Conditions: Macular Degeneration
Being tested: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
Keywords: Neovascular Age-Related Macular Degeneration
Medical subject headings: Macular Degeneration

What participants receive

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

aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological
Also called VEGF Trap-Eye, BAY86-5321
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological
Also called VEGF Trap-Eye, BAY86-5321
Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological
Also called VEGF Trap-Eye, BAY86-5321
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological
Also called VEGF Trap-Eye, BAY86-5321
Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Biological
Also called VEGF Trap-Eye, BAY86-5321
Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.

Study groups in NCT00320788
Study group	Role	What they receive
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4	Experimental	Not described Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12	Experimental	Not described Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4	Experimental	Not described Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12	Experimental	Not described Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12	Experimental	Not described Receives: Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

What is being measured

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

Mean Change of CR/LT From Baseline at Week 12
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.
Measured: Baseline and at Week 12

Secondary outcomes (3)

Mean Percent Change of CR/LT From Baseline at Week 12
CR/LT measured in micrometers (µm); a more negative percentage represents a better outcome
Measured: Baseline and at Week 12
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Measured: Baseline and at week 12
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
Defined study baseline range of ETDRS Best Corrected Visual Acuity of: letter score of 73 to 25 (20/40 to 20/320) in the study eye; a higher score represents better functioning
Measured: At Week 12

Timeline

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

Apr 2006Aug 2008

First posted3 May 2006 (estimated)
Study startApr 2006
Primary completionJun 2008
Study completionAug 2008

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 159 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00320788
Sponsor's protocol ID: VGFT-OD-0508
Status last verified: Jan 2012
First submitted: 28 Apr 2006
Last updated: 1 Mar 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.
PubMed 39207600
Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
PubMed 32374423

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Macular Degeneration trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Controlled Study of the Safety, Tolerability and Biological Effect of Repeated Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration
ClinicalTrials.gov ID: NCT00320788
Acronym / sponsor ID: VGFT-OD-0508
Conditions: Macular Degeneration
Keywords: Neovascular Age-Related Macular Degeneration
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 159 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: Bayer
Study start: Apr 2006
Primary completion: Jun 2008 (actual)
Study completion: Aug 2008 (actual)
First posted: 3 May 2006 (estimated)
Results: Posted 1 Mar 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study examines the effect of intravitreally administered VEGF Trap in patients with wet AMD.

Detailed description

After Week 12, patients will be evaluated every 4 weeks. Patients will remain on study or may be eligible to enter a long-term extension study, in which they will continue to receive VEGF Trap.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 5

Arm	Type	Receives
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4	Experimental	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12	Experimental	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4	Experimental	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12	Experimental	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)
aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12	Experimental	Biological: aflibercept injection (VEGF Trap-Eye, BAY86-5321)

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 ≥ 300 µm as measured by Optical Coherence Tomography (OCT).
Early Treatment of Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity of 73 letters to 34 letters.

Key exclusion criteria (13 listed)

History of any vitreous hemorrhage within 4 weeks prior to Day 1.
Aphakia.
Significant subfoveal atrophy or scarring.
Prior treatment with the following in the study eye:
Presence of any other condition or laboratory abnormality, which, in the opinion of the Investigator, would interfere with the assessment of disease status/progression or jeopardize the patient's appropriate participation in this Phase II 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
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Also: VEGF Trap-Eye, BAY86-5321Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12	Biological	aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Also: VEGF Trap-Eye, BAY86-5321Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.	Biological	aflibercept injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Also: VEGF Trap-Eye, BAY86-5321Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12	Biological	aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Also: VEGF Trap-Eye, BAY86-5321Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.	Biological	aflibercept injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12
aflibercept injection (VEGF Trap-Eye, BAY86-5321)Also: VEGF Trap-Eye, BAY86-5321Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.	Biological	aflibercept injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12

Primary outcome

Mean Change of CR/LT From Baseline at Week 12
Time frame: Baseline and at Week 12
CR/LT measured in micrometers (µm); lower individual values represent better outcomes.

3 secondary outcomes

Mean Percent Change of CR/LT From Baseline at Week 12
Time frame: Baseline and at Week 12
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) From Baseline at Week 12
Time frame: Baseline and at week 12
Percentage of Participants Who Gained at Least 15 Letters of Vision in the ETDRS Letter Score From Baseline at Week 12
Time frame: At Week 12

Results and safety

Results posted to the registry on 1 Mar 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4	32	26
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12	32	26
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4	32	29
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12	32	27
Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12	31	26

Primary outcome: Mean Change of CR/LT From Baseline at Week 12

Time frame: Baseline and at Week 12. Mean (Standard Deviation). Unit: μm

Measure	Aflibercept Injection 0.5mg q4 n = 32	Aflibercept Injection 0.5mg q12 n = 32	Aflibercept Injection 2.0mg q4 n = 31	Aflibercept Injection 2.0mg q12 n = 31	Aflibercept Injection 4.0mg q12 n = 31	Total n = 157
Value	-153.5 (113.30)	-75.6 (110.64)	-169.2 (138.46)	-56.3 (133.05)	-139.8 (228.59)	-118.8 (155.31)

Population analysed: Full Analysis Set (FAS) used for analysis, Last Observation Carried Forward (LOCF)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events (AEs) considered related to study treatment were followed until resolution or until the event was considered chronic or stable.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aflibercept Injection 0.5mg q4	11 of ?	26 of ?	Not reported
Aflibercept Injection 0.5mg q12	5 of ?	25 of ?	Not reported
Aflibercept Injection 2.0mg q4	10 of ?	27 of ?	Not reported
Aflibercept Injection 2.0mg q12	7 of ?	22 of ?	Not reported
Aflibercept Injection 4.0mg q12	2 of ?	22 of ?	Not reported

Limitations and caveats (from the sponsor): This is a phase 2 study with small numbers of patients per group limiting the conclusions that can be drawn from the resulting data.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39207600Wazan LE, Widhibrata A, Liu GS. Soluble FLT-1 in angiogenesis: pathophysiological roles and therapeutic implications. Angiogenesis. 2024 Nov;27(4):641-661. doi: 10.1007/s10456-024-09942-8. Epub 2024 Aug 29.
Derived from this study: PubMed 32374423Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2.
Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration.Link provided by the sponsor.
The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing.Link provided by the sponsor.

Related trials for Macular Degeneration

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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

18 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 aflibercept injection (VEGF Trap-Eye, BAY86-5321) in people with Macular Degeneration, run by Regeneron Pharmaceuticals at 18 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 1 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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 1 Mar 2012). 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?

Mean Change of CR/LT From Baseline at Week 12 (time frame: Baseline and at 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 NCT00320788, which also lists 2 linked publications.

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 1 Mar 2012.