Safety and Tolerability Study of Intravitreal VEGF-Trap Administration in Patients With Neovascular AMD

Macular Degeneration Clinical Trial

Official title:

An Exploratory Study of the Safety, Tolerability and Biological Effect of Intravitreal Administration of VEGF Trap in Patients With Neovascular Age-Related Macular Degeneration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00320775
• Other study ID #: VGFT-OD-0502
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2006
• Last updated: March 16, 2015
• Start date: June 2005
• Est. completion date: August 2008

Study information

• Verified date: March 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

This study consists of three parts, Part A, Part B and Part C. Part A is a dose escalation. Part B was terminated early. The (one) subject who received Macugen is not discussed in this website. Part C had subjects receive one of two doses of VEGF Trap (0.15 mg or 4.0 mg).

This is the first study in which human subjects received intravitreal injections of VEGF Trap in a study eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Subfoveal CNV secondary to AMD.

• Central retinal/lesion thickness = 250µm as measured by optical coherence tomography (OCT).

• ETDRS best-corrected visual acuity of:

• 20/40 (73 letters) or worse

• Clear ocular media and clear lens(es) to permit good quality stereoscopic fundus photography.

Exclusion Criteria:

• Prior treatment with VEGF Trap, bevacizumab or ranibizumab.

• Any investigational agent within 12 weeks of Visit 2 (Day 1).

• Presence of other causes of CNV.

• Active ocular infection.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• VEGF Trap
Part A: Six successive cohorts of 3-6 patients each with neovascular AMD will receive a single intravitreal (ITV) injection of 0.05, 0.15, 0.5, 1.0, 2.0, or 4.0 mg of VEGF Trap into the study eye. Part B: Up to 30 subjects will be randomly assigned in a 1:1 ratio to receive a single of 2.0 mg/eye VEGF Trap followed by 1 sham injection six weeks later, or an initial dose of 0.3 mg pegaptanib sodium into the study eye, followed by a second dose six weeks later. Part C: Approximately 30 subjects will be randomly assigned in a 1:1 ratio to receive up to two ITV injections of either 0.15 or 4.0 mg/eye VEGF Trap. After completion of Visit 8 (Day 57), patients from all parts of the study, may be eligible to continue in Open-label Extension and will receive 4.0 mg of VEGF Trap.

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital School of Medicine	Baltimore	Maryland
United States	Charlotte Eye, Ear, Nose & Throat Asssociates	Charlotte	North Carolina
United States	University of Chicago	Chicago	Illinois
United States	Loma Linda University Health Care	Loma Linda	California
United States	Retina-Vitreous Associates, P.C.	Nashville	Tennessee
United States	Dean A. McGee Eye Institute	Oklahoma City	Oklahoma
United States	Retina Diagnostic and Treatment Assoc., LLC	Philadelphia	Pennsylvania
United States	Retina Centers, PC	Tuscon	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Bayer

Country where clinical trial is conducted

United States, 

References & Publications (2)

Do DV, Schmidt-Erfurth U, Gonzalez VH, Gordon CM, Tolentino M, Berliner AJ, Vitti R, Rückert R, Sandbrink R, Stein D, Yang K, Beckmann K, Heier JS. The DA VINCI Study: phase 2 primary results of VEGF Trap-Eye in patients with diabetic macular edema. Ophth — View Citation

Nguyen QD, Campochiaro PA, Shah SM, Browning DJ, Hudson HL, Sonkin PL, Hariprasad SM, Kaiser PK, Slakter J, Haller JA, Do DV, Mieler W, Chu K, Ingerman A, Vitti R, Berliner AJ, Cedarbaum J; Clear-It 1 Investigators. Evaluation of very high- and very low-d — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability, bioeffect		From baseline to Day 43	Yes
Secondary	The effect of VEGF Trap administration on excess central retinal/lesion thickness		From baseline to Day 43	No
Secondary	Best-corrected Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity		From baseline to Day 43	No
Secondary	Extent of CNV leakage		From baseline to Day 43	No
Secondary	Anti-VEGF Trap antibodies in the systemic circulation		From baseline to Day 43	No
Secondary	Plasma levels of VEGF Trap		From baseliene to Day 43	No

External Links

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