Safety and efficacy of intravitreal injections of ranibizumab/Lucentis in combination with verteporfin photodynamic therapy (PDT) in patients with choroidal neovascularisation (CNV) secondary to age related macular degeneratio

• Conditions: 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.

• Registration Number: EUCTR2006-002977-33-SI
• Lead Sponsor: niversity Eye Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-21
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 10

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:
oEvidence that CNV extends under the geometric center of the foveal avascular zone.
oThe area of the CNV must occupy at least 50% of the total lesion.
oThe 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:
oBlood associated with the lesion at baseline
oLoss of VA in the previous 3 months defined as either
o=5 letters (ETDRS equivalent) as determined by protocol refraction and protocol measurement
OR
o2 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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: ;Primary end point(s): 1.The mean change from baseline in best corrected visual acuity (BCVA) at months 3, 6 and 12.<br>2.The mean change from baseline in total size of lesion and area of leakage at months 3, 6 and 12. <br>;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.