Ranibizumab and Reduced Fluence PDT for AMD - Full Text View

Sponsors and Collaborators:	Texas Retina Associates Novartis
Information provided by:	Texas Retina Associates
ClinicalTrials.gov Identifier:	NCT00527475

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 II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Bevacizumab Ranibizumab Verteporfin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration

Further study details as provided by Texas Retina Associates:

Primary Outcome Measures:

The primary outcome will be the percentage of patients with less than 15 letters of visual loss at 12 months. [ Time Frame: 1 year ]

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 ]

Estimated Enrollment:	60
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
Group I: Active Comparator 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
Group II: Experimental 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:

Willingness to sign informed consent.
Age greater than 50.
Evidence of macular degeneration in the form of drusen in either eye.
Visual acuity of 20/25 to 20/800.
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
Total active lesion must be less than 12 disc areas in size. -

Exclusion Criteria:

Myopia, ocular histoplasmosis, or other retinal pathology that could affect vision
Previous treatment of the enrolled eye for CNV
Intraocular surgery within 6 weeks of enrollment
Geographic atrophy, subretinal fibrosis, or pigment epithelial tear involving the fovea of the eligible eye
Known hypersensitivity to verteporfin
Medical condition that would preclude regular follow-up for one year.
Previous vitrectomy
Media opacities limiting visual acuity, retinal examination, or retinal imaging.
A lesion where > 50% of the lesion is a pigment epithelial detachment. -

Contacts and Locations

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

Contacts

Contact: David Callanan, MD

817-261-9625

Locations

United States, California
California Retina Consultants & Research Foundation	Recruiting
Santa Barbara, California, United States, 93103
Principal Investigator: Bob Avery, MD
United States, Michigan
Associated Retinal Consultants	Recruiting
Ann Arbor, Michigan, United States, 49301
Contact: Joan Videtich
Principal Investigator: Tom Aaberg, Jr., MD
United States, Texas
Texas Retina Associates	Recruiting
Arlington, Texas, United States, 76012
Contact: Patricia Bradley pbradley@texasretina.com
Principal Investigator: David Callanan, MD
Sub-Investigator: Wayne Solley, MD
Sub-Investigator: Patrick Williams, MD
Sub-Investigator: Gary Edd Fish, MD

Sponsors and Collaborators

Texas Retina Associates

Novartis

Investigators

Study Chair:

David Callanan, MD

Texas Retina Associates

More Information

Study ID Numbers:	RAP AMD Trial
Study First Received:	September 9, 2007
Last Updated:	September 9, 2007
ClinicalTrials.gov Identifier:	NCT00527475
Health Authority:	United States: Food and Drug Administration

Keywords provided by Texas Retina Associates:

Anti-VEGF therapy
photodynamic therapy
neovascularization

Study placed in the following topic categories:

Metaplasia
Eye Diseases
Choroid Diseases
Verteporfin
Retinal Degeneration
Macular Degeneration

Bevacizumab
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration
Choroidal Neovascularization

Additional relevant MeSH terms:

Photosensitizing Agents
Uveal Diseases
Pathologic Processes
Radiation-Sensitizing Agents

Therapeutic Uses
Physiological Effects of Drugs
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009