Ranibizumab and Reduced Fluence PDT for AMD (RAP)

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Texas Retina Associates
ClinicalTrials.gov Identifier:
NCT00527475
First received: September 9, 2007
Last updated: June 5, 2013
Last verified: June 2013

September 9, 2007
June 5, 2013
May 2007
January 2010   (final data collection date for primary outcome measure)
The Percentage of Patients With Less Than 15 Letters of ETDRS Visual Loss at 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
The primary outcome will be the percentage of patients with less than 15 letters of visual loss at 12 months. [ Time Frame: 1 year ]
Complete list of historical versions of study NCT00527475 on ClinicalTrials.gov Archive Site
The Number of Days to Retreatment. The Total Number of Treatments Given Over One Year. The Percentage of Patients With More Than a 15 Letter Increase in Vision at 12 Months. The Mean Change in Macular Volume as Measured by OCT at 3, 6, and 12 Months. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
The number of days to retreatment. The total number of treatments given over one year. The percentage of patients with more than a 15 letter increase in vision at 12 months. The mean change in macular volume as measured by OCT at 3, 6, and 12 months. [ Time Frame: 1 year ]
Not Provided
Not Provided
 
Ranibizumab and Reduced Fluence PDT for AMD
Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration

Single agent anti-VEGF therapies such as ranibizumab have shown great promise and have set the standard for visual outcomes in treating wet macular degeneration. However, they need to be administered frequently by intraocular injections with the attendant risk of endophthalmitis, lens damage, retinal detachment, and vitreous hemorrhage. The purpose of this trial is to see if using photodynamic therapy in combination with ranibizumab will decrease the number of treatments with ranibizumab.

A randomized, prospective, multicenter trial will compare two groups of patients with subfoveal choroidal neovascularization secondary to AMD. One group will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year. The other group will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year. Re-treatment will be determined by the individual investigator based on visual acuity, retinal thickness as measured by optical coherence tomography (OCT), and fluorescein angiography. Visual acuity and OCT measurements will be performed by masked examiners.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Macular Degeneration
  • Drug: ranibizumab
    0.5 mg. given as an intraocular injection
  • Drug: verteporfin
    Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.
  • Active Comparator: Group I
    Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
    Intervention: Drug: ranibizumab
  • Experimental: Group II
    Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
    Interventions:
    • Drug: ranibizumab
    • Drug: verteporfin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Willingness to sign informed consent.
  2. Age greater than 50.
  3. Evidence of macular degeneration in the form of drusen in either eye.
  4. Visual acuity of 20/25 to 20/800.
  5. Subfoveal choroidal neovascularization. Both occult and classic subtypes will be allowed. If lesion is purely occult there has to be one of the following:

    1. Recent loss of vision (5 letters on ETDRS or doubling of visual angle by snellen)
    2. Documented enlargement of lesion on FA
    3. Increase of 50 microns or more in the central subfield on OCT
    4. New blood
  6. Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria:

  1. Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
  2. Previous treatment of the enrolled eye for CNV
  3. Intraocular surgery within 6 weeks of enrollment
  4. Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
  5. Known hypersensitivity to verteporfin
  6. Medical condition that would preclude regular follow-up for one year.
  7. Previous vitrectomy
  8. Media opacities limiting visual acuity, retinal examination, or retinal imaging.
  9. A lesion where > 50% of the lesion is a pigment epithelial detachment. -
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00527475
RAP AMD Trial
No
Texas Retina Associates
Texas Retina Associates
Novartis
Study Chair: David Callanan, MD Texas Retina Associates
Texas Retina Associates
June 2013

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