Clinical trial NCT00383370: Safety and Tolerability of Intravitreal VEGF Trap Formulations in Subjects With Neovacular AMD
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neovascular Age Related Macular Degeneration
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-10-03
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Myers
country: United States
state: Florida
city: Wichita
country: United States
state: Kansas
city: Hagerstown
country: United States
state: Maryland
city: Columbia
country: United States
state: South Carolina
city: Austin
country: United States
state: Texas
city: McAllen
country: United States
state: Texas
Study officials:
affiliation: Regeneron Pharmaceutical
name: Avner Ingerman, MD
role: STUDY_DIRECTOR
References: