Macular Degeneration: Soucek P

Soucek P, Soucková I. · Oftalmologická klinika FNKV, Praha. · Cesk Slov Oftalmol. · Pubmed #18780651 No free full text.

Abstract: PURPOSE: To evaluate safety and efficacy of intravitreal ranibizumab (IVR) combined with verteporfin photodynamic therapy (PDT) in neovascular macular degeneration. METHODS: Ten eyes of ten patients received one IVR 0.5 mg after verteporfin PDT (standard regimen), then the treatment has been indicated PRN (pro re nata; when necessary). Patients were examined to exclude acute disease, which could prevent to initiate the treatment. Eyes were evaluated, with ETDRS the best-corrected visual acuity (BCVA), intraocular pressure, and slit lamp and after pupil dilatation biomicroscopy and optical coherence tomography (OCT) at baseline and monthly thereafter. Fluorescein angiography (FA) was performed at baseline and after three months. In the study group, there were two cases (20%) of new idiopathic choroidal neovascularization and 8 patients (80%) who were previously treated at least once by verteporfin due to age-related macular degeneration. Another session of IVR would be performed in case of 5-letter decrease of BCVA, 100-microm increase of central retinal thickness (CRT) or new hemorrhages in the macula. Next verteporfin PDT therapy would be indicated in case of a leakage on FA. The mean BCVA before the treatment was of 0.3, CRT of 228 microm and macular volume of 6.79 mm3. The mean follow-up was 3.5 months. RESULTS: There were no BCVA decrease, OCT increase bigger than stated above or new hemorrhages at any visit (n = 25). There was no leakage on any FA at month 3 (n = 10). That is why only one session of combined verteporfin PDT and IVR was performed in all patients (100 %). The mean BCVA improved to 0.5 (mean increase by 13.5 letters), CRT dropped to 198 microm and macular volume to 6.33 mm3. No systemic or ocular side effects were noted. CONCLUSION: Longer follow-up and larger study group are mandatory to confirm early positive results of this therapy (improvement by 13.5 letters after one session of combination of verteporfin PDT and RIV) which seems to be the most promising due to absence of serious complications with smoother disease management and lower financial burden.

Azab M, Boyer DS, Bressler NM, Bressler SB, Cihelkova I, Hao Y, Immonen I, Lim JI, Menchini U, Naor J, Potter MJ, Reaves A, Rosenfeld PJ, Slakter JS, Soucek P, Strong HA, Wenkstern A, Su XY, Yang YC, Anonymous00313. · No affiliation provided · Arch Ophthalmol. · Pubmed #15824216 No free full text.

Abstract: OBJECTIVE: To compare the treatment effect and safety of photodynamic therapy with verteporfin using a standard (SF) or reduced (RF) light fluence rate with that of placebo therapy in patients with subfoveal minimally classic choroidal neovascularization (CNV) with age-related macular degeneration. DESIGN: Phase 2, multicenter, double-masked, placebo-controlled, randomized clinical trial. SETTING: Nineteen ophthalmology practices in North America and Europe. PARTICIPANTS: Patients with initial best-corrected visual acuity of at least 20/250 and a lesion size of no greater than 6 Macular Photocoagulation Study (MPS) disc areas. METHODS: We randomly assigned 117 patients (1:1:1) to verteporfin infusion (6 mg/m(2)) and light application with an RF rate (300 mW/cm(2)) for 83 seconds (light dose of 25 J/cm(2)) or an SF rate (600 mW/cm(2)) for 83 seconds (light dose of 50 J/cm(2)) or to placebo infusion with RF or SF. Treatment was repeated every 3 months if the treating physician noted fluorescein leakage from CNV on angiography. Patients in whom a predominantly classic lesion developed could receive open-label standard verteporfin treatment. Best-corrected visual acuity was measured every 3 months, and angiographic changes were assessed by the Photograph Reading Center through the 3-month examination unless an ocular adverse event or conversion to a predominantly classic lesion was identified by an investigator. Safety was assessed throughout the study. All outcomes were on an intent-to-treat basis. RESULTS: One hundred three (88%) of 117 patients completed the 24-month examination. Twelve (30%) of 40 patients assigned to placebo received open-label standard verteporfin treatment after confirmation of presence of predominantly classic CNV. At month 12, a loss of at least 3 lines of visual acuity occurred in 5 (14%) of 36 eyes assigned to RF and 10 (28%) of 36 eyes assigned to SF, compared with 18 (47%) of 38 eyes assigned to placebo (RF, P = .002; SF, P = .08; RF + SF, P = .004). At month 24, this loss occurred in 9 (26%) of 34 eyes assigned to RF and 17 (53%) of 32 assigned to SF, compared with 23 (62%) of 37 eyes assigned to placebo (RF, P = .003; SF, P = .45; RF + SF, P = .03). Progression to predominantly classic CNV by 24 months was more common in the placebo group (11 [28%] of 39 patients compared with 2 [5%] of 38 in the RF group [P = .007] and 1 [3%] of 37 in the SF group [P = .002]). No unexpected ocular or systemic adverse events were identified. Treatment-related, usually transient visual disturbances were 13% with SF, 10% with placebo, and 5% with RF. CONCLUSIONS: Verteporfin therapy safely reduced the risks of losing at least 15 letters (> or =3 lines) of visual acuity and progression to predominantly classic CNV for at least 2 years in individuals with subfoveal minimally classic lesions due to age-related macular degeneration measuring 6 MPS disc areas or less. Based on the overall evidence available on verteporfin therapy for these lesions, the VIM Study Group would consider recommending verteporfin therapy for relatively small minimally classic lesions similar to those enrolled in the VIM Trial.

Cihelková I, Soucek P. · Ocní klinika FNKV, Praha. · Cesk Slov Oftalmol. · Pubmed #12951876 No free full text.

Abstract: Findings on Optical Coherence Tomography in Macular Degeneration with Predominantly Classic Subfoveal Choroidal Neovascularization Treated by Photodynamic Therapy with Visudyne. We determined findings on optical coherence tomography (OCT) in macular degeneration with predominantly classic subfoveal choroidal neovascularization treated by photodynamic therapy (PDT) with Visudyne. We performed 21 correlations of central retinal thickness (CRT) on OCT2 with findings on fluorescein angiography (FA) in our study. We quantified CRT on OCT2 in 14 cases before, during and after the end of the treatment. The control group was composed from patients, who were not able to undergo the treatment and therefore it was postponed. CRT on OCT correlated with FA in 95% of cases in our study. Maximal decreasee of CRT is demonstrated during the first three months of treatment. Values of CRT on OCT are in patients after repeated sessions of PDT lower than before the first session. These values can grow up a little for some time due to increase of amount of intraretinal fluid during the first week after the session of PDT. During next follow-up there are no big differences between values of CRT. In the control group CRT on OCT increases progressively during the follow-up.

Soucek P, Cihelková I. · The Eye Department, University Hospital, Srobárova 50, 100-34 Prague, Czech Republic. · Neuro Endocrinol Lett. · Pubmed #12195243 No free full text.

Abstract: Our controlled case describes the drug possibility to stabilize the exudative form of Age-related Macular Degeneration. The new approach of selective destruction of choroidal neovascularization (CNV) can be applied in patients with subfoveal lesions. Photodynamic therapy (PDT) is based on the reaction of photoactivable drug with the light of low-energy laser beam. So far only verteporfin [Visudyne, Novartis] as sensitizer is marketed and laser with wavelength of 689 nm is used. But it is questionable whether to apply this very costly treatment to extremely old people. An example of treatment of 90-year old woman with AMD with classic form of CNV is presented. Her BCVA was 0.05 OD. She underwent four session of PDT. At the last visit (eighteen months after initial and ten months after last session of PDT) the BCVA remained 0.05 OD. The patient is using a special magnifying lens for reading achieving near vision of 0.32. The presented example indicates the necessity of detailed study of every case to promote the therapeutic decisions for the benefit of progress in the field.

Soucek P, Boguzsaková J, Cihelková I. · Ocní klinika FNKV, Praha. · Cesk Slov Oftalmol. · Pubmed #12046251 No free full text.

Abstract: Photodynamic therapy with the preparation Visudyne (PDT) is the only treatment which retards statistically significantly the decline of vision in patients with age related and myopic macular degeneration with a subfoveal, predominantly classic choroidal neovascularization. The authors present their own experience with the treatment of the first 12 patients. During 6-month treatment a loss of more than 3 lines of ETDRS optotypes was recorded in two patients (17%). The presented results of FTV are consistent with data published abroad. As the one-year therapeutic results in two patients are encouraging, it will be necessary in future to prolong the follow up time and increase the number of patients.