A phase IV non-randomized, uncontrolled, open-label, single-center trial to evaluate the safety and efficacy of Macugen (pegaptanib sodium) given by intravitreal injections every 6 weeks in patients with serous pigment epithel detachments (PED) in exudative age-related macular degeneration (AMD)
- Conditions
- neovascular (wet) age-related macular degeneration (AMD)MedDRA version: 8.1Level: LLTClassification code 10025411Term: Macular degeneration senile
- Registration Number
- EUCTR2006-006312-30-HU
- Lead Sponsor
- Dept. of Ophthalmol, Semmelweis University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 30
•Patients of either gender
•Age: 50 years or above
•diagnosed with early lesions of serous pigment epithel detachments secondary to AMD
Early lesion defined as:
•best corrected visual acuity >= 20/100,
•detachments measuring < 6 disc areas
•absence of any scarring/fibrosis or atrophy within the lesion
•the absence of subfoveal hemorrhage or total hemorrhage representing greater than 1 disc area
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Patients with prior treatment with PDT, or subfoveal laser and with clinically significant concomitant diseases will be excluded.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The purpose of the study is to evaluate the safety and efficacy of Macugen in a special subgroup of AMD patients.;Secondary Objective: ;Primary end point(s): proportion of patients losing <15 letters of distance visual acuity (ETDRS) at 54 weeks
- Secondary Outcome Measures
Name Time Method