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. 2010 Oct 5;4:1073-9.
doi: 10.2147/OPTH.S13969.

Lucentis Using Visudyne Study: Determining the Threshold-Dose Fluence of Verteporfin Photodynamic Therapy Combined With Intravitreal Ranibizumab for Exudative Macular Degeneration

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Free PMC article

Lucentis Using Visudyne Study: Determining the Threshold-Dose Fluence of Verteporfin Photodynamic Therapy Combined With Intravitreal Ranibizumab for Exudative Macular Degeneration

Eric Chen et al. Clin Ophthalmol. .
Free PMC article

Abstract

Purpose: Combination verteporfin photodynamic therapy (vPDT) and antivascular endothelial growth factor (anti-VEGF) therapy may decrease the need for injections while maintaining visual acuity in exudative age-related macular degeneration. This pilot study was designed to determine the threshold fluence dose of vPDT (the dose required to demonstrate an effect on choroidal perfusion) combined with ranibizumab.

Methods: Seven patients were randomized to sham vPDT (two patients), 20% fluence vPDT (two patients), or 40% fluence vPDT (three patients) in combination with three-monthly intravitreal 0.5 mg ranibizumab injections. Intravitreal ranibizumab was reinjected if disease activity was seen on fluorescein angiography, optical coherence tomography, or clinical examination. Indocyanine green-determined choroidal hypoperfusion was graded in a masked fashion.

Results: Patients with 20% vPDT had mild hypoperfusion defects at seven days that resolved by week 4 (threshold dose); patients with 40% fluence vPDT had marked hypoperfusion at seven days that persisted as long as 12 months. Recruitment was stopped after limited efficacy was observed. One patient with 20% fluence vPDT lost 19 letters at one year; no other patient lost or gained >10 letters. Central retinal thickness decreased in six of seven patients, but ranibizumab injections did not decrease.

Conclusion: This pilot study shows that the threshold fluence dose of vPDT (when combined with ranibizumab) is approximately 20% standard fluence, and that mild and transient choroidal hypoperfusion can occur. Forty percent fluence vPDT causes a more prolonged and striking hypoperfusion. Despite hypoperfusion, no decrease in visual acuity or injections required was noted, suggesting that even higher fluence levels of vPDT may be necessary to decrease the number of anti-VEGF injections.

Keywords: choroidal hypoperfusion; neovascular age-related macular degeneration; threshold dose; verteporfin photodynamic therapy.

Figures

Figure 1
Figure 1
Results of logMAR BCVA over the 12 months of the study. Patient 3 (20% vPDT fluence) lost 19 letters at one year, but no other patient in any arm lost or gained >10 letters at one year by ETDRS refracted visual acuity.
Figure 2
Figure 2
Results of OCT central retinal thickness over the 12 months of the study. Central retinal thickness decreased in every patient by the end of the study except in patient 3. At baseline CRT was 268 in the sham group, 252 in the 20% fluence group, and 298 in the 40% fluence group, and at one year CRT was 239, 292, and 215 respectively.
Figure 3
Figure 3
Early and late ICG of patient 2 (0% fluence vPDT). There is no evidence of choroidal hypoperfusion at any time point.
Figure 4
Figure 4
Early and late ICG of patient 4 (20% fluence vPDT). By day 7 after vPDT, there is a mild but definitive area of choroidal hypoperfusion in the area of treatment (yellow arrows). By one month, this defect has resolved.
Figure 5
Figure 5
Early and late ICG of patient 5 (40% fluence vPDT). As early as day 1 after vPDT, there is an area of superior choroidal hypoperfusion (red arrows) that becomes more pronounced by day 7. This finding persists through month 9 of the study.

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