Elsevier

Ophthalmology

Volume 113, Issue 1, January 2006, Pages 23-28
Ophthalmology

Original Article
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.
https://doi.org/10.1016/j.ophtha.2005.10.012Get rights and content

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.

Section snippets

Materials and Methods

The study population has been described previously.6 In summary, individuals with a best-corrected VA letter score between 68 and 25 (approximate Snellen equivalent between 20/50 and 20/320) in the study eye and DME involving the center of the macula for whom the investigator judged macular photocoagulation could be safely withheld for 16 weeks were included. Subjects were excluded if they had untreated high-risk proliferative diabetic retinopathy, were judged likely to need scatter

Baseline Information and Treatments

Of 172 participants in the phase II DME study, 19 were noted at baseline to have retinal neovascularization by the Photograph Reading Center. One of these 19 individuals (enrolled as a protocol deviation) was excluded from this report because scatter photocoagulation was applied 13 days before randomization (0.3-mg group), and 2 additional subjects were excluded because follow-up photographs were not available (1 in the 3-mg group and 1 in the sham group).

Of the remaining 16 subjects (Table 1),

Discussion

To our knowledge, this is the first report to be published in the peer-reviewed literature documenting regression of retinal neovascularization as observed on fundus photographs and angiograms in individuals with diabetic retinopathy after selective VEGF165 blockade. Specifically, pegaptanib sodium, an anti-VEGF aptamer that selectively binds VEGF165, given as a series of intravitreous injections, was followed by regression of neovascularization or loss of neovascularization as determined on

References (12)

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    Indeed, the rationale for anti-VEGF therapy for DME follows data showing that VEGF levels were increased in the retina and vitreous of eyes with DR.28 Furthermore, increased vitreous and plasma VEGF levels have been shown to be prognostic of worsening in patients with PDR undergoing vitrectomy.28 In 1 multicenter study, most subjects with retinal neovascularization at baseline who were assigned to the pegylated anti-VEGF aptamer pegaptanib for the treatment of DME also showed regression of neovascularization during follow-up.29 Thus, the current evidence suggests that anti-VEGF therapy targets one of the major underlying pathologic pathways in DR that is responsible not only for worsening DME, but also for worsening of DR severity.

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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: [email protected].

Reprint requests to Michael Altaweel, MD, 2870 University Avenue, Suite 206, Madison, WI 53705. E-mail: [email protected].

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.

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