Changes in Retinal Neovascularization after Pegaptanib (Macugen) Therapy in Diabetic Individuals
Presented in part at: American Academy of Ophthalmology annual meeting, October, 2005; Chicago, Illinois.
Received 23 August 2005; accepted 10 October 2005. published online 12 December 2005.
Objective
To study effects of intravitreal pegaptanib (Macugen) on retinal neovascularization.
Design
Retrospective analysis of a randomized clinical trial.
Participants, Intervention, and Main Outcome Measures
Individuals with retinal neovascularization identified from a multicenter, randomized, controlled trial evaluating pegaptanib for treatment of diabetic macular edema, with a best-corrected visual acuity letter score between 68 and 25 (approximate Snellen equivalent between 20/50 and 20/320) and receiving a sham injection or intravitreal pegaptanib (0.3 mg, 1 mg, 3 mg) administered at study entry, week 6, and week 12, with additional injections and/or focal photocoagulation as needed during the ensuing 18 weeks, up to a maximum of 6 pegaptanib/sham therapies, were evaluated. Scatter panretinal photocoagulation before study enrollment was permitted, but not within 6 months of randomization and study entry. Changes in retinal neovascularization were assessed on fundus photographs and fluorescein angiograms graded at a reading center in a masked fashion.
Results
Of 172 participants, 19 had retinal neovascularization in the study eye at baseline. Excluding 1 who had scatter photocoagulation 13 days before randomization and 2 with no follow-up photographs, 1 of the remaining 16 subjects had panretinal photocoagulation during study follow-up. Of these 16 subjects, 8 of 13 (62%) in a pegaptanib treatment group (including the one receiving panretinal photocoagulation), 0 of 3 in the sham group, and 0 of 4 fellow (nonstudy) eyes showed either regression of neovascularization on fundus photographs or regression or absence of fluorescein leakage from neovascularization (or both) at 36 weeks. In 3 of 8 with regression, neovascularization progressed at week 52 after cessation of pegaptanib at week 30.
Conclusions
Most subjects with retinal neovascularization at baseline assigned to pegaptanib showed regression of neovascularization by week 36. These findings suggest a direct effect of pegaptanib upon retinal neovascularization in patients with diabetes mellitus.
Manuscript no. 2005-796.
The study was sponsored by Eyetech Pharmaceuticals, Inc., New York, New York, and Pfizer Inc., New York, New York.
1 Correspondence to Neil M. Bressler, MD, Suite 115, 550 North Broadway, Baltimore, MD 21205-2002. E-mail: nmboffice@jhmi.edu.
Reprint requests to Michael Altaweel, MD, 2870 University Avenue, Suite 206, Madison, WI 53705. E-mail: mmaltaweel@wisc.edu.
⁎ Members of a Writing Committee from the Study Group, chaired by Michael Altaweel, MD (University of Wisconsin, Madison, Wisconsin), take authorship responsibility for this article, had complete access to the data needed for it, and are listed in the “Appendix” with pertinent financial conflicts of interest.
ABSTRACT