Age related macular degeneration (AMD) is the leading cause of blindness in individuals older than 50 years in the developed world. Eighty to ninety percent of rapid and severe vision loss due to AMD is attributable to the so called »wet form« characterized by newly formed blood vessels from choroidea (choroidal neovascularization, CNV). These blood vessels permeate blood and fluid, causing fibrosation of macula and degeneration of photoreceptors.
Conditions
Interventions
Product Name: ranibizumab
Product Code: RFB002
Pharmaceutical Form: Solution for injection
Trade Name: Visudyne (verteporfin)
Product Name: Visudyne (verteporfin)
Product Code: BPD952
Pharmaceutical
Sponsors
University Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who at baseline • have a BCVA letter score in the study eye between 73-24 (approximately 20/40 to 20/320) using an ETDRS chart measured at 4 meters or Snellen equivalent • have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography: o Evidence that CNV extends under the geometric center of the foveal avascular zone. o The area of the CNV must occupy at least 50% of the total lesion. o The lesion must be =5400 microns in greatest linear dimension (GLD) • for occult with no classic CNV, the lesion must have presumed recent disease progression as assessed by the Investigator and defined as having at least one of the following criteria: o Blood associated with the lesion at baseline o Loss of VA in the previous 3 months defined as either o =5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurement OR o 2 or more lines using a Snellen or equivalent chart by standard examination o =10% increase in the GLD as assessed by fluorescein angiography in the previous 3 months 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 • Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as “low dose” up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study • Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded • History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.) • History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with topical anti-glaucomatous medication). • Aphakia or absence of the posterior capsule in the study eye • Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation • Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia • Presence of a retinal pigment epithelial tear involving the macula in the study eye • Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia • Active intraocular inflammation (grade trace or above) in the study eye • Any active infection involving an eyeball adnexa • Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) for the treatment of subfoveal CNV secondary to AMD.;Secondary Objective: ;Primary end point(s): 1.The mean change from baseline in best corrected visual acuity (BCVA) at months 3, 6 and 12. 2.The mean change from baseline in total size of lesion and area of leakage at months 3, 6 and 12. | — |
Countries
Slovenia
Outcome results
None listed