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 degeneration

niversity Eye Hospital0 sites10 target enrollmentAugust 21, 2006

DrugsVisudyne (verteporfin)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: niversity Eye Hospital
Enrollment: 10
Status: Active, not recruiting
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 21, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

niversity Eye Hospital

Eligibility 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:
•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

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