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CompletedNCT00429962Updated Apr 7, 2009

Study Comparing Ranibizumab Monotherapy With Combined Verteporfin Therapy in Subfoveal CNV

A Phase 3 interventional study of intravitreal ranibizumab and intravitreal ranibizumab & photodynamic therapy in Choroidal Neovascularization and Age-Related Macular Degeneration, sponsored by University Hospital, Basel, Switzerland. Completed at 1 site in Switzerland. Open to participants aged 50 Years to 95 Years. Per ClinicalTrials.gov, last updated 2009-04-07.

Sponsored by University Hospital, Basel, Switzerland · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 95 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

  • Choroidal Neovascularization
  • Age-Related Macular Degeneration

Keywords

  • subfoveal choroidal neovascularization (CNV)
  • age-related macular degeneration
  • ranibizumab monotherapy
  • combined verteporfin-therapy
  • Lucentis® (ranibizumab)
  • Visudyne®
  • photodynamic therapy
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 40 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 968 studies on the registry; 191 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    A

    intravitreal ranibizumab used in combination with verteporfin photodynamic therapy

    Drug: intravitreal ranibizumab & photodynamic therapy

  • Active comparator
    B

    intravitreal ranibizumab

    Drug: intravitreal ranibizumab

Interventions

  • Drugintravitreal ranibizumab

    intraocular injection

    Also known as: Lucentis

  • Drugintravitreal ranibizumab & photodynamic therapy

    intraocular injection photodynamic treatment (LASER) after intravenous injection

    Also known as: Visudyne

06

What researchers measure

Primary outcomes

  1. First injection with PDT

    Time frame: monthly

Secondary outcomes

  1. Monthly clinical evaluation of safety and necessity of re-intravitreal injection of ranibizumab after three initial injections

    Time frame: monthly

07

Study locations

1 site
  • University Eye Clinic
    Basel, Basel-Stadt 4031, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00429962
Lead sponsor
University Hospital, Basel, Switzerland
First posted
Feb 1, 2007
Start date
Jul 2006
Primary completion
Jun 2008
Completion
Jun 2008
Last update
Apr 7, 2009

Study contacts

Ulrike Schneider, MD
study director · University Eye Clinic Basel

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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