Patients with choroidal neovascularization secondary to pathologic myopia. MedDRA version: 6.1 Level: PT Classification code 10060823
Conditions
Interventions
Trade Name: MACUGEN
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Pegaptanib sodium
Concentration unit: µg/µl microgram(s)/microlitre
Concentration type: equal
Concentration number:
Sponsors
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Choroidal neovascularization secondary to pathologic myopia (distance correction of at least -6.0 D, or less than -6.0 D but with retinal abnormalities consistent with pathologic myopia, and an axial length at least 26.5 mm) Choroidal neovascularization under the geometric center of the foveal avascular zone Area of choroidal neovascularization at least 50% of the area of the total neovascular lesion Greatest linear dimension no more than 5400 m Best-correct visual acuity letter score of at least 50 (Snellen equivalent 20/100 or better) Willing and able to provide written informed consent. 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: Features of any condition other than pathologic myopia associated with choroidal neovascularization in study eye Tear (rip) of the retinal pigment epithelium Any significant ocular disease that has compromised or could compromise vision in the study eye and confound analysis of the primary outcome Inability of obtain photographs to document choroidal neovascularization History of treatment for choroidal neovascularization in study eye other than nonfoveal confluent laser photocoagulation Participation in another ophthalmic clinical trial or use of any other investigational new drugs within 12 weeks before the start of study treatment Prior photodynamic therapy for choroidal neovascularization Intraocular surgery within last 2 months or capsulotomy within last months in study eye Women in pregnancy and breast-feeding or women who have intention of having one pregnancy in the period of time of duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of Pegaptanib in myopic neovascular lesions after 1 year from the first treatment.;Secondary Objective: Not pertinent.;Primary end point(s): To evaluate the safety of Pegaptanib on visual acuity. | — |
Countries
Italy
Outcome results
None listed