Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Treatments: Ranibizumab; Verteporfin

Criteria

Inclusion Criteria:

1. 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

2. Best corrected visual acuity score between 24-73 letters (20/40 to 20/320) (ETDRS 4 m)

Exclusion Criteria:

1. Prior treatment with mit Laser, PDT, Macugen, TA

2. Prior treatment with radiatio, vitrectomy, transpupillary thermotherapy

3. History of surgical intervention in the study eye within two months preceding day 1

4. concurrent use of systemic anti-VEGF agents

5. previous treatment with or participation in a clinical trial involving anti-angiogenic drugs (Pegaptanib, ranibizumab, anecortave acetate of corticosteroids).

6. 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

7. Retinal pigment epithelium tear, vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye

8. History of idiopathic or autoimmune-associated uveitis in either eye, active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye

9. 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.)

10. Glaucoma with IOP>25 mmHg despite therapy

11. Aphakia or absence of the posterior capsule in the study eye

12. Spherical equivalent >-8