Elsevier

Ophthalmology

Volume 116, Issue 1, January 2009, Pages 100-105.e1
Ophthalmology

Original article
Prospective Clinical Trial Evaluating the Efficacy of Photodynamic Therapy for Symptomatic Circumscribed Choroidal Hemangioma

Presented in part at: American Academy of Ophthalmology, November 12, 2007, New Orleans, Louisiana, as a free paper (PA 067). It was given the “Best Paper” award at the ocular tumors and pathology session.
https://doi.org/10.1016/j.ophtha.2008.08.029Get rights and content

Purpose

To evaluate photodynamic therapy (PDT) for symptomatic circumscribed choroidal hemangioma (CCH).

Design

Prospective, multicenter, nonrandomized clinical trial.

Participants

Thirty-one eyes of 31 patients with posterior pole CCH and symptoms caused by exudation into the macular area.

Intervention

Photodynamic therapy was applied by Zeiss laser. Intravenous verteporfin at 6 mg/m2 body surface was administered before treatment, and light emitted at 689 nm for photosensitization. The treatment spot diameter was calculated on early-phase frames of pretreatment indocyanine green angiography. Fifteen minutes after starting the verteporfin infusion, the laser beam was applied to the retina at radiant exposure 50 J/cm2 and exposure time 83 seconds. One to 4 treatments were applied at 12-week intervals over 1 year. Standardized evaluation was performed before and at 4-week intervals after each treatment, and at 3, 6, 9, and 12 months. All patients were followed for ≥12 months.

Main Outcome Measures

The primary outcome measure was the absence of exudative retinal detachment at the 12-month follow-up visit on ophthalmoscopy, fluorescein angiography, and optical coherence tomography. Secondary measures were the visual acuity outcome, with best-corrected visual acuity determined by the Early Treatment for Diabetic Retinopathy Study chart, tumor thickness decrease on B-scan ultrasonography, and adverse events.

Results

Among the total, 82.8% of patients required 1, 13.8% 2, and 3.4% 3 PDTs to eliminate exudative retinal detachment. Visual acuity increased from a mean of 20/60 to 20/35 (P<0.001). Sixty-nine percent of patients demonstrated visual recovery (P<0.001). Cystoid macular edema regressed in all cases and exudative macular detachment disappeared in all but 2 cases. The CCH thickness decreased in all cases from a mean of 3.0 to 1.7 mm, with the most intense effect seen after 4 weeks of treatment (P<0.001). Visual fields showed resolution of central scotomas. There were no severe adverse events.

Conclusions

Combining PDT with the standard age-related macular degeneration protocol is an effective treatment for CCH in terms of resolution of exudative subretinal fluid and recovery of VA.

Financial Disclosure(s)

The authors have no proprietary or commercial interest in any materials discussed in this article.

Section snippets

Methods

This is a prospective, nonrandomized, multicenter clinical trial carried out in 10 centers in Spain. The trial started on January 12, 2005, and enrollment ended on October 25, 2005. The study protocol was approved by the Ethics Committees of all participating hospitals.

One eye from each of 31 patients was included in this clinical trial. The diagnosis of CCH was based on findings obtained by ophthalmoscopy, indocyanine green (ICG) and fluorescein angiography, and B-scan ultrasonography.

All

Results

The study included 17 men and 12 women with a mean age of 48.6±14.6. Presenting symptoms included blurred vision in all patients with a mean time from onset of 24.6 months. Metamorphopsia and scotoma were present in 58.6% and 48.3%, respectively.

Seven angiomas (24.1%) had been treated previously: 5 with laser (2 of these also with transpupillary thermotherapy) and 2 with transpupillary thermotherapy. The CCH was located at the macula in 68.9% (subfoveal 10.3%, juxtafoveal 24.1%, extrafoveal

Discussion

This study presents the only clinical trial and the largest prospective study reported to date of CCH treated with PDT. Regarding the natural history of this condition, the most complete clinical study of CCH is contained in the published reports of a group of patients from the Wills Eye Hospital. The latest report29 includes 200 patients, among whom 81% had exudative retinal detachment at the time of presentation. The clinical manifestations and factors predictive of final visual outcome are

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    Manuscript no. 2008-288.

    Financial Disclosure(s): The authors have no proprietary or commercial interest in any materials discussed in this article.

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