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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

January 31, 2007
April 6, 2009
July 2006
June 2008   (final data collection date for primary outcome measure)
First injection with PDT [ Time Frame: monthly ] [ Designated as safety issue: No ]
  • Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections
  • First injection with PDT
Complete list of historical versions of study NCT00429962 on ClinicalTrials.gov Archive Site
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 ]
Not Provided
Not Provided
Not Provided
 
Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV
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
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
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Choroidal Neovascularization
  • Age-Related Macular Degeneration
  • Drug: intravitreal ranibizumab
    intraocular injection
    Other Name: Lucentis
  • Drug: intravitreal ranibizumab & photodynamic therapy
    intraocular injection photodynamic treatment (LASER) after intravenous injection
    Other Name: Visudyne
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Both
50 Years to 95 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00429962
081-PRC-2006-005
No
Not Provided
Not Provided
Selim Orgul, University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Study Director: Ulrike Schneider, MD University Eye Clinic Basel
University Hospital, Basel, Switzerland
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP