Subjects of either gender aged > 50 years, diagnosed with subfoveal CNV secondary to AMD, a predominantly occult lesion composition, and with best corrected visual acuity of 20/40 to 20/200 in the absence of subfoveal atrophy or scarring in the trial eye.
Conditions
Interventions
Product Name: Macugen
Product Code: Pegaptanib
Pharmaceutical Form:
Other descriptive name: Macugen
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 3
Sponsors
Ludwig Boltzmann Institute forRetinology and Biomicroscopic Laser Surgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: age > 50 years predominantly occult CNV greatest diameter of the lesion 0.1 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
Exclusion criteria
Exclusion criteria: Any of the following will exclude a subject from the study: Complicating general disorders inflicting with healing process vision threatening diseases other than CNV Prior treatment for CNV Ophthalmic surgery within 4 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: There is a decrease in retinal thickness;Secondary Objective: Number of adverse events, number of PDT treatments VEGF levels of aqueous humor and serum in three groups of the study populationDistance acuityDiameter of the lesion;Primary end point(s): retinal thickness | — |
Countries
Austria
Outcome results
None listed