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
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: ranibizumab
Drug: verteporfin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Texas Retina Associates:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: May 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: ranibizumab
0.5 mg. given as an intraocular injection
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.
Drug: ranibizumab
0.5 mg. given as an intraocular injection
Drug: verteporfin
Standard dosage of 6 mgs. / meter2 of body surface area given intravenously.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00527475

Locations
United States, California
California Retina Consultants & Research Foundation
Santa Barbara, California, United States, 93103
United States, Michigan
Associated Retinal Consultants
Ann Arbor, Michigan, United States, 49301
United States, Texas
Texas Retina Associates
Arlington, Texas, United States, 76012
Sponsors and Collaborators
Texas Retina Associates
Novartis
Investigators
Study Chair: David Callanan, MD Texas Retina Associates
  More Information

No publications provided

Responsible Party: Texas Retina Associates
ClinicalTrials.gov Identifier: NCT00527475     History of Changes
Other Study ID Numbers: RAP AMD Trial
Study First Received: September 9, 2007
Results First Received: April 19, 2013
Last Updated: June 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Texas Retina Associates:
Anti-VEGF therapy
photodynamic therapy
neovascularization

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
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014