Status:
COMPLETED
Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
Lead Sponsor:
University Hospital, Basel, Switzerland
Conditions:
Choroidal Neovascularization
Age-Related Macular Degeneration
Eligibility:
All Genders
50-95 years
Phase:
PHASE3
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 f...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00429962
Start Date
July 1 2006
End Date
June 1 2008
Last Update
April 7 2009
Active Locations (1)
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1
University Eye Clinic
Basel, Canton of Basel-City, Switzerland, 4031