Randomized, Single-Masked, Long-Term, Safety and Tolerability Study of VEGF Trap-Eye in AMD

Macular Degeneration Clinical Trial

Official title:

A Randomized, Single-Masked , Long-Term, Safety and Tolerability Study of Intravitreal VEGF Trap-Eye in Subjects With Neovascular Age-related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527423
• Other study ID #: VGFT-OD-0702
• Status: Completed
• Phase: Phase 2
• First received: September 6, 2007
• Last updated: June 10, 2013
• Start date: August 2007
• Est. completion date: October 2011

Study information

• Verified date: June 2013
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Rollover study for subjects in prior VEGF Trap-Eye Phase I and II studies. Primary objective is to assess long-term safety and tolerability of continuing intravitreal treatment in subjects with wet age-related macular degeneration.

Description:

Randomized, Single-Masked Phase II study for subjects previously enrolled in Phase I and II studies for wet age-related macular degeneration with VEGF Trap-Eye intravitreal injection as treatment.Long term (3 years) treatment is intended to measure safety and tolerability, as well as frequency of re-treatment and the effect of VEGF Trap-Eye on best corrected visual acuity (BCVA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 157
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Prior participation in VEGF Trap-Eye Phase I and II studies

Exclusion Criteria:

• Any ocular or systemic adverse events that would preclude participation

• Presence of any condition that would jeopardize subject's participation

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• VEGF Trap Eye
Intravitreal injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AE)	Number of participants with AEs summarized by category	Baseline of this study to Wk 152	Yes
Secondary	Frequency (Number of Injections)	Frequency (number of injections) of PRN treatment from baseline of this study to week 152 (end of treatment).	Baseline of this study to Wk 152	Yes
Secondary	Mean Change From Baseline of Original Study in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score of Study Eye - Observed Values	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.	Baseline of original study to Wk 156	No