Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD (NCT00383370) | Clinical Trial Compass
CompletedPhase 1
Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
United States20 participantsStarted 2006-10
Plain-language summary
To assess the safety and tolerability of repeated intravitreal (ITV) administration of VEGF Trap.
Who can participate
Age range50 Years
SexALL
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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
What they're measuring
1
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.