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

Study Overview
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Brief Summary
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To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.

Detailed Description
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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.

Official Title
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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

Conditions
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Neovascular Age Related Macular Degeneration

Intervention / Treatment
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* Drug: VEGF Trap
* Biological: VEGF Trap


Participation Criteria
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Eligibility Criteria
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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. 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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ITV-1<br>VEGF Trap formulation 1 | Drug: VEGF Trap<br>* VEGF Trap formulation 1, ITV-1<br>* Other names: ITV-1;|
| Experimental: ITV-2<br>VEGF Trap formulation 2 | Drug: VEGF Trap<br>* VEGF Trap formulation 1, ITV-1<br>* Other names: ITV-1;|
| Experimental: ITV-2 OL<br>VEGF Trap formulation 2 open label, higher concentration | Biological: VEGF Trap<br>* VEGF Trap formulation 2 at higher concentration in Open label cohort<br>* Other names: ITV-2;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 12 weeks |