Faculty Bibliography

PURPOSE: To evaluate safety and efficacy of the angiostatic agent anecortave acetate, compared with a placebo, for treatment of subfoveal choroidal neovascularization (CNV). DESIGN: Ongoing masked, randomized, placebo-controlled, parallel evaluation of anecortave acetate (30 mg, 15 mg, and 3 mg) versus a placebo. PARTICIPANTS: There were 128 eyes of 128 patients with subfoveal CNV secondary to age-related macular degeneration who were enrolled and treated, with 80% (102/128) of eyes presenting with predominantly classic lesions at baseline. METHODS: All eyes received a posterior juxtascleral depot application of masked study medication or a placebo, with retreatment at 6-month intervals if the masked investigator believed the patient could benefit. Patients received periodic detailed ophthalmic examinations with both fluorescein and indocyanine green angiography, general physical examinations with electrocardiograms, and hematology/serum chemistry/urinalysis. All ophthalmic and systemic safety data were periodically reviewed by the Independent Safety Committee overseeing the study. MAIN OUTCOME MEASURES: Best-corrected logarithm of the minimum angle of resolution (logMAR) vision and fluorescein angiographic lesion characteristics were compared over time and among treatment groups. RESULTS: At month 12, anecortave acetate (15 mg) administered at 6-month intervals was statistically superior to the placebo for 3 measures of clinical efficacy: mean change from baseline vision (P = 0.0131), stabilization of vision (<3 logMAR line change; P = 0.0323), and prevention of severe vision loss (decrease of > or = 6 logMAR lines from baseline; P = 0.0224). Subgroup analysis of predominantly classic lesions revealed that anecortave acetate (15 mg) was also superior to the placebo at 1 year for each of these 3 measures of visual outcome (Ps = 0.0022, 0.0100, and 0.0299, respectively). Anecortave acetate (15 mg) trended toward significance over the placebo at month 12 for inhibition of total lesion growth and for inhibition of both the total CNV component and the classic CNV component in both the overall and subgroup analyses. The Independent Safety Committee identified no clinically relevant treatment-related safety issues. CONCLUSIONS: Anecortave acetate (15 mg) is safe and clinically efficacious at 1 year for maintaining vision, preventing severe vision loss, and inhibiting subfoveal CNV lesion growth

BACKGROUND: Most patients with central serous chorioretinopathy (CSC) have spontaneous resolution of exudative macular detachments and a good visual prognosis. Patients with CSC have a primary choroidal hyperpermeability problem evident as multifocal areas of hyperpermeability during indocyanine green (ICG) angiography. A small percentage of patients develop chronic or progressive disease with widespread decompensation of the retinal pigment epithelium and severe vision loss. There is no known treatment for this variant of the disorder. PURPOSE: To study ICG-guided photodynamic therapy (PDT) with verteporfin as a potential treatment for patients with chronic CSC. METHODS: Twenty eyes of 15 patients were studied with fluorescein angiography, optical coherence tomography, and ICG angiography to diagnose the maculopathy, monitor the detachments, and localize the choroidal hyperpermeability of the disorder. PDT with ICG guidance was applied to areas of choroidal hyperpermeability, and the patients were observed to determine the anatomic and functional outcomes. RESULTS: Photodynamic therapy guided by ICG was associated with complete resolution of exudative macular detachments in 12 patients and incomplete resolution in the remaining eight eyes. The vision improved in six eyes and remained unchanged in 14 eyes during a mean follow-up of 6.8 months. Six weeks after treatment, the mean visual acuity improved by 0.55 lines, an amount that was marginally significant. There was a significant inverse correlation between the baseline visual acuity and the amount of improvement in acuity at 6 weeks. No patient had any treatment-related side effects. CONCLUSIONS: Indocyanine green angiography-guided PDT with verteporfin seems to aid in the resolution of exudative detachments in patients with chronic CSC. This treatment was associated with a rapid reduction in subretinal fluid and improvement in visual acuity. Although the follow-up time and number of patients in this pilot study were limited, the encouraging results and lack of complications suggest that further study is indicated

This paper demonstrates the clinical application of a multiplanar imaging system, which simultaneously acquires en-face (C-scan) OCT and corresponding confocal ophthalmoscopic images along with cross-sectional (B-scan) OCT at cursor designated locations on the confocal image. Advantages of the simultaneous OCT/confocal acquisition as well as the challenges of interpreting the C-scan OCT images are discussed. Variations in tissue inclination with respect to th coherence wave surface alters the sampling of structures within the depth in the retina, producing novel slice orientations which are often challenging to interpret. We evaluate for the first time the utility of C-scan OCT for a variety of pathologies including exudative ARMD, macular hole, central serous retinopathy, diabetic retinopathy, polypoidal choroidal vasculopathy and macular pucker. Several remarkable observations of new aspects of clinical anatomy were noted. The versatility of selective capture of C-scan OCT images and B-scan OCT images at precise points on the confocal image affords the clinician a more complete and interactive tool for 3D imaging of retinal pathology

PURPOSE: To study the effects of photodynamic therapy using verteporfin in the treatment of patients with subfoveal polypoidal choroidal vasculopathy (PCV). METHODS: A retrospective chart review of 16 consecutive patients with subfoveal PCV treated with photodynamic therapy using verteporfin was performed. RESULTS: The mean age of the patients involved was 70.5 years. The mean follow-up time was 12 months. The visual acuity improved in 9 (56.3 %), remained the same in 5 (31.3 %), and decreased in 2 (12.5 %). The mean change in visual acuity was an improvement of 2.38 lines, a difference that was highly significant ( = 0.004). The change in visual acuity was negatively correlated with increasing age. The final visual acuity was positively correlated with initial acuity and negatively correlated with age. These results were confirmed by multiple linear regression. No patient had any lasting complication from the treatment. CONCLUSIONS: Subfoveal PCV has no proven method of treatment. Although the follow-up time and the number of patients in this pilot study were limited, the encouraging results and lack of complications suggest that further study is indicated

PURPOSE: To study the effects of photodynamic therapy (PDT) using verteporfin on the treatment of patients with subfoveal choroidal neovascularization (CNV) secondary to multifocal choroiditis and panuveitis (MCP), an uncommon disorder with no proven forms of therapy. METHODS: A retrospective chart review of seven consecutive patients with subfoveal CNV secondary to MCP treated with PDT using verteporfin was performed. RESULTS: The mean age of the 7 patients (all myopic women) was 41.4 years. A mean of 1.86 treatments was performed, and the mean follow-up time was 10 months. Four of the seven patients were treated unsuccessfully with corticosteroids before referral for PDT. The mean improvement of visual acuity was 0.86 line; 3 patients (42.8%) had an improvement in visual acuity representing at least a halving of their visual angle, while the other 4 patients remained stable. There were no treatment-related side effects. CONCLUSIONS: Although the follow-up time and the number of patients in this study were limited, the use of PDT was associated with stabilization or improvement of visual acuity in patients with subfoveal CNV secondary to MCP. Further study of this treatment modality is indicated

Objective: Guidelines were developed based on best available scientific data as well as consensus of expert opinion in absence of controlled clinical trial data to: 1) assist ophthalmologists with selection of patients for whom photodynamic therapy with verteporfin, termed 'verteporfin therapy,' should be considered; and 2) offer suggestions regarding treatment, follow-up, and re-treatment. Methods: Consensus from roundtable of retina specialists who either participated in randomized clinical trials evaluating verteporfin therapy or had clinical experience with verteporfin therapy was based on results of these trials and expert opinion. Additional input and advice were received from representatives on behalf of the Macula Society, the Retina Society, and the Vitreous Society, as well as principal investigators of randomized clinical trials evaluating verteporfin therapy. Results: Patient selection criteria included the following: 1) in cases due to age-related macular degeneration (AMD), lesion composition either predominantly classic choroidal neovascularization (CNV) or occult with no classic CNV; 2) CNV location subfoveal or so close to the foveal center that conventional laser photocoagulation treatment almost certainly would extend under the center; 3) lesion etiology from AMD, pathologic myopia, or other causes in which the outcome without treatment is likely to be worse than with treatment; 4) vision at a level where further loss would be recognized as detrimental to the quality of life of the patient. Criteria did not include lesion size, except in cases composed of occult with no classic CNV in AMD in which therapy for lesions >4 Macular Photocoagulation Study (MPS) disc areas usually should be considered only when presenting with lower levels of best-corrected visual acuity. Criteria also did not include patient age, history of systemic arterial hypertension, or prior laser photocoagulation. Therapy should occur ideally within 1 week of the initial fluorescein angiogram on which the clinical decision to treat is based. Patients should return for follow-up at least as often as every 3 months after any initial or subsequent treatment to determine if there is fluorescein leakage from CNV. Re-treatment should be considered as often as every 3 months if fluorescein leakage from CNV is noted at that time. Re-treatment could be deferred if the biomicroscopic and fluorescein angiographic appearance of the lesion is unchanged and shows minimal leakage, especially when there is no subretinal fluid or fluorescein leakage from CNV underlying the center of the foveal avascular zone. Patients should avoid exposure of skin or eyes to direct sunlight or bright indoor light for 48 hours after treatment or until resolution of any swelling or discoloration from extravasation. Conclusion: These recommendations provide guidelines on the role of verteporfin therapy in the management of CNV due to AMD and other causes. Revisions of these guidelines may be required as new data become available. $$: