Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

NCT ID: NCT00429962

Last Updated: 2009-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-06-30

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

Conditions

Choroidal Neovascularization; Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

A

intravitreal ranibizumab used in combination with verteporfin photodynamic therapy

Group Type: EXPERIMENTAL

intravitreal ranibizumab & photodynamic therapy

Intervention Type: DRUG

intraocular injection photodynamic treatment (LASER) after intravenous injection

B

intravitreal ranibizumab

Group Type: ACTIVE_COMPARATOR

intravitreal ranibizumab

Intervention Type: DRUG

intraocular injection

Interventions

intravitreal ranibizumab

intraocular injection

Intervention Type: DRUG

intravitreal ranibizumab & photodynamic therapy

intraocular injection photodynamic treatment (LASER) after intravenous injection

Intervention Type: DRUG

Other Intervention Names

Lucentis; Visudyne

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Basel, Switzerland

Principal Investigators

Ulrike Schneider, MD

Role: STUDY_DIRECTOR

University Eye Clinic Basel

Locations

University Eye Clinic

Basel, Canton of Basel-City, Switzerland

Countries

Switzerland

Other Identifiers

081-PRC-2006-005

Identifier Type: -

Identifier Source: org_study_id