neovascular Age-related Macular Degeneration
Conditions
Interventions
Trade Name: Lucentis
Pharmaceutical Form: Injection*
INN or Proposed INN: Ranibizumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0,5-
Trade Name: Visudyne
Pha
Sponsors
Ludwig Boltzmann Institut für Retinologie und biomikroskopische Laserchirurgie
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The study population will consist of male and female patients > 50 years of age with subfoveal choroidal neovascularization (CNV) secondary to AMD. 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: · Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes · Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy · Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye · Focal laser photocoagulation (juxta-, extra- or subfoveal) in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to explore whether intravitreal ranibizumab in monotherapy or in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD, change of distance acuity at month 12;Secondary Objective: safety assessment number of required Ranibizumab injections;Primary end point(s): -Best corrected visual acuity (BCVA) worsened less than 5 letters compared to the BCVA at month 2 OR -Retinal thickness at the central subfield as assessed by OCT increased less than 100µm compared to the thickness at month 2 | — |
Countries
Austria
Outcome results
None listed