subfoveal choroidal neovascularization secondary to age-related macular degeneration MedDRA version: 9.1 Level: LLT Classification code 10060823 Term: Choroidal neovascularisation
Conditions
Interventions
Trade Name: VISUDYNE
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: VERTEPORFINA
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equal
Sponsors
IRCCS- FONDAZIONE G.B. BIETTI PER LO STUDIO E LA RICERCA IN OFTALMOLOGIA-ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patients of any race 50 years or older with subfoveal CNV secondary to AMD(all types of lesion).The total area of CNV encompassed within the lesion must be>50% of the total lesion area.The total lesion area must have the greatest linear dimension ≤5400 microns(9 MPS Disc Areas). BCVA letter score in the study eye between 73 and 24 (approximately 20/40 to 20/320 Snellen Equivalent) using an ETDRS chart measured at 4 meters distance. 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 prior treatments with Visudyne, Macugen, Lucentis(Ranibizumab), Avastin(Bevacizumab) or other anti-angiogenic or corticosteroid intravitreal treatment in the study eye; Prior external-beam radiation, subfoveal focal laser photocoagulation, transpupillary thermotherapy,pars plana vitrectomy in the study eye; History of intraocular surgery in the study eye except for uncomplicated cataract surgery more than 90 days prior to treatment; History of YAG-laser posterior capsulotomy in the study eye within 30 days prior treatment; Use of non steroid antinflammatory drugs during the study; Presence of angioid streaks, presumed ocular histoplasmosis syndrome, pathologic myopia(8 or more D); Presence of fibrosis,hemorrage, pigment epithelial detachments or other hypofluorescent lesions obscuring greater than 50% of the CNV lesion; Tear (rip) of the retinal pigment epithelium; Vitreal hemorrage,retinal detachment or macular hole; Epiretinal membrane; Uncontrolled glaucoma in the study eye(defined as intraocular pressure, IOP ≥ 25 mmHG despite treatment with two or more topical pharmacological antiglaucomatous medication); Active or history of ocular inflammation or infection; Aphakia and posterior capsule tear; Pregnant or nursing(lactating) women; Women of child-bearing potential unless they meet the following definition of postmenopausal; Any systemic medical condition that may interfere with the safety of the patient; Positive anamnesis for tumor in last the 5 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to evaluate the safety and the efficacy of ranibizumab administered in conjunction with photodynamic therapy in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) and to evaluate if this treatment reduces the total number of ranibizumab retreatment and permittes a the treatment-free interval longer.;Secondary Objective: Evaluate: Percentage of the patients that gain ≥5 ≥10 ≥15 Letters, BCVA at 3,6,12 months; Percentage of the patients that lose <15 letters at 3,6,12 months; Mean BCVA change and change of the total area of the lesion from baseline; Change of fluorangiographic leakage at 3,6,12 months from baseline; Retinal sensitivity change measured with microperimetry.;Primary end point(s): Evaluate mean BCVA change at 3,6,12 months from baseline using an ETDRS chart measured at 4 meters distance; Evaluate the number of retreatments, the treatment ?free interval and the percentage of retreated patients at 3,6,12 months; leakage change at 3,6,12 months from baseline. | — |
Countries
Italy
Outcome results
None listed