Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

Tracking Information
First Submitted Date ICMJE	January 31, 2007
First Posted Date ICMJE	February 1, 2007
Last Update Posted Date	April 7, 2009
Study Start Date ICMJE	July 2006
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 6, 2009)	First injection with PDT [ Time Frame: monthly ]
Original Primary Outcome Measures ICMJE; (submitted: January 31, 2007)	Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections; First injection with PDT
Change History	Complete list of historical versions of study NCT00429962 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 6, 2009)	Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections [ Time Frame: monthly ]
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
Official Title ICMJE	Randomized, Phase IIIb Study Comparing Safety, Tolerability and Efficacy Between Lucentis® Administered in Conjunction With PDT With Visudyne® and Lucentis® in Patients With Subfoveal CNV Secondary to Age-Related Macular Degeneration
Brief Summary	This pilot study is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne®) compared to ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD
Detailed Description	Intravitreal ranibizumab has shown to increase average vision in patients with subfoveal CNV secondary to AMD. However, the treatment does not provide benefit to all patients and the treatment regimen requires monthly intravitreal injections. Ranibizumab is an anti-VEGF-A monoclonal antibody fragment. Verteporfin photodynamic therapy acts through occluding newly formed vessels. The combination of these therapies acting through different modes of action bears the potential to provide a more convenient and less frequent therapy while maintaining/improving the increase in vision improvement observed with ranibizumab monotherapy. The strategic goal is to evaluate whether intravitreal ranibizumab in combination with verteporfin photodynamic therapy is an effective, safe and convenient treatment for patients with subfoveal CNV secondary to AMD and explore potential advantages of such treatment compared to ranibizumab monotherapy
Study Type ICMJE	Interventional
Study Phase	Phase 3
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
Condition ICMJE	Choroidal Neovascularization; Age-Related Macular Degeneration
Intervention ICMJE	Drug: intravitreal ranibizumab intraocular injection Other Name: Lucentis; Drug: intravitreal ranibizumab & photodynamic therapy intraocular injection photodynamic treatment (LASER) after intravenous injection Other Name: Visudyne
Study Arms	Experimental: A intravitreal ranibizumab used in combination with verteporfin photodynamic therapy Intervention: Drug: intravitreal ranibizumab & photodynamic therapy; Active Comparator: B intravitreal ranibizumab Intervention: Drug: intravitreal ranibizumab
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 31, 2007)	40
Original Enrollment ICMJE	Same as current
Actual Study Completion Date	June 2008
Actual Primary Completion Date	June 2008 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	Inclusion Criteria: patients over 50 years, subfoveal CNV of any type secondary to age-related macular degeneration (AMD), no "macula-treatment for the last 30 days (e.g. with PDT, TA, Laser, Macugen®). the area of the CNV must occupy at least >50% of the lesion (total lesion size under 5400 microns in greatest linear dimension) Occult CNV: recent disease progression bleeding VA decreased the last three months >5 letters or 2 or more than two lines (Snellen) 10% increase of the lesion size the last three months; Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m) Exclusion Criteria: Prior treatment with mit Laser, PDT, Macugen, TA; Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy; History of surgical intervention in the study eye within two months preceding day 1; concurrent use of systemic anti-VEGF agents; previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids).; Ocular disorders in the study eye that may confound interpretation of the study results, including retinal detachment or macular hole (Stage 3 or 4), active intraocular inflammation (grade trace or above) or persistent macular edema due to uveitis or other inflammatory diseases; Retinal pigment epithelium tear, vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye; History of idiopathic or autoimmune-associated uveitis in either eye, active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye; Extracapsular extraction of cataract with phacoemulsification within two months preceding day 1, or a history of post-operative complications within the last 12 months preceding day 1 or a history of post-operative complications within the last 12 months preceding day 1 in the study eye (uveitis, cyclitis, iritis etc.); Glaucoma with IOP>25 mmHg despite therapy; Aphakia or absence of the posterior capsule in the study eye; Spherical equivalent >-8
Sex/Gender	Sexes Eligible for Study: All
Ages	50 Years to 95 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Switzerland
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00429962
Other Study ID Numbers ICMJE	081-PRC-2006-005
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Selim Orgul, University Hospital, Basel, Switzerland
Study Sponsor ICMJE	University Hospital, Basel, Switzerland
Collaborators ICMJE	Not Provided
Investigators ICMJE	Study Director: Ulrike Schneider, MD University Eye Clinic Basel
PRS Account	University Hospital, Basel, Switzerland
Verification Date	April 2009
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP