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Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

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

NCT00383370•Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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)

Exclusion Criteria

•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);
•* 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.
+3 more criteria

Locations (6)

Fort Myers, Florida, United States

Wichita, Kansas, United States

Hagerstown, Maryland, United States

Columbia, South Carolina, United States

Austin, Texas, United States

McAllen, Texas, United States

Key Dates

Start Date

October 1, 2006

Primary Completion Date

September 1, 2007

Completion Date

July 1, 2008

Last Updated

April 21, 2011

Enrollment

ACTUAL participants

Conditions

Neovascular Age Related Macular Degeneration

Interventions

VEGF Trap

DRUG

VEGF Trap

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 21, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Open-label, Randomized Clinical Trial to Evaluate the Efficacy, Durability, and Safety of Aflibercept 8mg in Different Treatment Regimens in Chinese Patients With Polypoidal Choroidal Vasculopathy (PCV)

A Study to Assess the Effects of Brolucizumab in Adult Patients With Neovascular Age Related Macular Degeneration

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