Ranibizumab and Reduced Fluence PDT for AMD
Information source: Texas Retina Associates
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: ranibizumab (Drug); verteporfin (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Texas Retina Associates Official(s) and/or principal investigator(s):
David Callanan, MD, Study Chair, Affiliation: Texas Retina Associates
Overall contact:
David Callanan, MD, Phone: 817-261-9625
Summary
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.
Clinical Details
Official title: Ranibizumab and Reduced Fluence Photodynamic Therapy for Choroidal Neovascularization in Age Related Macular Degeneration
Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The primary outcome will be the percentage of patients with less than 15 letters of visual loss at 12 months.
Secondary outcome: 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.
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
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
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. -
Locations and Contacts
David Callanan, MD, Phone: 817-261-9625
California Retina Consultants & Research Foundation, Santa Barbara, California 93103, United States; Recruiting
Bob Avery, MD, Principal Investigator
Associated Retinal Consultants, Ann Arbor, Michigan 49301, United States; Recruiting
Joan Videtich
Tom Aaberg, Jr., MD, Principal Investigator
Texas Retina Associates, Arlington, Texas 76012, United States; Recruiting
Patricia Bradley, Email: pbradley@texasretina.com
David Callanan, MD, Principal Investigator
Wayne Solley, MD, Sub-Investigator
Patrick Williams, MD, Sub-Investigator
Gary Edd Fish, MD, Sub-Investigator
Additional Information
Starting date: May 2007
Ending date: December 2008
Last updated: September 9, 2007
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