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Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00429962
First received: January 31, 2007
Last updated: April 6, 2009
Last verified: April 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Choroidal Neovascularization
Age-Related Macular Degeneration
 Drug: intravitreal ranibizumab
Drug: intravitreal ranibizumab & photodynamic therapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • First injection with PDT [ Time Frame: monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections [ Time Frame: monthly ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
intravitreal ranibizumab used in combination with verteporfin photodynamic therapy
 Drug: intravitreal ranibizumab & photodynamic therapy
intraocular injection photodynamic treatment (LASER) after intravenous injection
Other Name: Visudyne
Active Comparator: B
intravitreal ranibizumab
 Drug: intravitreal ranibizumab
intraocular injection
Other Name: Lucentis

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

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00429962

Locations
Switzerland
University Eye Clinic
Basel, Basel-Stadt, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Study Director: Ulrike Schneider, MD University Eye Clinic Basel
  More Information

No publications provided

Responsible Party: Selim Orgul, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00429962     History of Changes
Other Study ID Numbers: 081-PRC-2006-005
Study First Received: January 31, 2007
Last Updated: April 6, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
subfoveal choroidal neovascularization (CNV)
age-related macular degeneration
ranibizumab monotherapy
combined verteporfin-therapy
 Lucentis® (ranibizumab)
Visudyne®
photodynamic therapy

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
 Uveal Diseases
Verteporfin
Photosensitizing Agents
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013