Methods

We retrospectively reviewed the therapeutic outcomes of 29 eyes of 29 patients with PCV who were treated at Gunma University Hospital between February 2007 and January 2008 with full-fluence PDT combined with 1.25 mg IVB within 1 week before PDT. The institutional review board approved the study protocol.

The inclusion criteria for this study were patient age older than 50 years, symptomatic PCV in the macular area, best-corrected visual acuity (BCVA) of 0.7 or worse, and a greatest linear dimension (GLD) of 6000 μm or less. The exclusion criteria were CNV caused by other diseases, such as pathologic myopia (spherical equivalent, ≤ −6 diopters); any contraindications to fluorescein angiography (FA), indocyanine green angiography (ICGA), verteporfin, or bevacizumab; the presence of an RPE tear; uncontrolled hypertension; a recent myocardial infarction; or cerebral vascular accidents. The enrolled patients were followed up for 12 months after the first treatment.

PCV was diagnosed based on the presence of polyplike choroidal vessel dilatation with or without a branching vascular network on ICGA using a confocal scanning laser ophthalmoscope (Heidelberg Retina Angiograph; Heidelberg Engineering, Heidelberg, Germany). The polypoidal lesions were either a single polyp or a cluster of polyps.

We evaluated the outcomes of 29 eyes based on the data at 12 months after the first treatment. Three eyes were excluded from the 32 consecutive eyes enrolled at baseline because they dropped out during the 12-month study. None of the 3 patients appeared at the hospital after 6 months. The BCVAs of these 3 eyes at baseline were 0.5, 0.09, and 0.1, and the BCVAs at the final visit at 6 months were 0.9, 0.15, and 0.4. The examinations included measurement of the BCVA (Landolt ring tests), FA, and ICGA using a Topcon fundus camera (TRC50LX/ImageNet2000; Topcon, Tokyo, Japan), Heidelberg Retina Angiography, spectral-domain optical coherence tomography (OCT, Cirrus OCT; Humphrey Instruments, San Leandro, California, USA; or 3D OCT1000;Topcon Corp, Tokyo, Japan). OCT and fundus images were obtained at baseline and at 1, 3, 6, 9, and 12 months later. FA and ICGA were performed every 3 months until the final treatment.

BCVA was measured as decimal visual acuity using a Landolt chart and converted to logarithm of the minimal angle of the resolution for statistical analysis. We defined improvement of VA as a logarithm of the minimal angle of the resolution VA improvement of 0.3 or more; VA loss was defined as a decline of 0.3 or more; VA was considered stable if it remained within 0.3. A paired t test was used to determine the significance of the difference in the logarithm of the minimal angle of the resolution VA before and after combined therapy. After providing informed consent, all patients were treated with an IVB injection (1.25 mg/0.05 mL) 3.5 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia. PDT was administered 7 days after the IVB injection. PDT with verteporfin (Visudyne; Novartis Pharma K.K., Tokyo, Japan) was performed in accordance with the standard protocol using a 689-nm laser system (Carl Zeiss Japan, Tokyo, Japan) that delivered 50 J/mm ² during an 83-second exposure time. We calculated the GLD based on the findings of ICGA. The GLD covered the entire PCV lesion, including the polypoidal lesions and the branching vascular network vessels. Additional treatment with PDT and IVB was considered every 3 months based on ICGA, FA, and OCT findings. The end point of the treatment was resolution of the macular exudative changes, which were confirmed by OCT and the resolution of the active polypoidal lesions on ICGA. The OCT images were used to evaluate the exudative changes of the lesions (subretinal fluid, intraretinal edema, serous or hemorrhagic pigment epithelial detachment [PED], and subretinal hemorrhage).

Results

The Table shows the clinical data from the 29 Japanese patients (29 eyes) at baseline and after treatment. All 29 eyes diagnosed with PCV on ICGA were classified as having occult with no classic CNV (27 eyes; 93%) or predominantly classic CNV (2 eyes; 7%) using FA. The mean BCVA levels at baseline and 1, 3, 6, 9, and 12 months after treatment were 0.25, 0.31, 0.39, 0.44, 0.44, and 0.45, respectively ( Figure 1 ). A significant improvement in the mean BCVA from baseline was observed using the paired t test at 1 month ( P = .014), 3 months ( P < .01), 6 months ( P < .01), 9 months ( P < .01), and 12 months ( P < .01). The mean change in BCVA at 1, 3, 6, 9, and 12 months from baseline was an increase of 1.07, 2.10, 2.59, 2.52, and 2.69 lines, respectively. All eyes (100%) had stabilized VA 3 months after combined therapy. At 3 months, the BCVA in 9 eyes (31%) improved by 3 lines or more, and the BCVA was stable in 20 eyes (69%). The VA did not decrease in any eyes ( Figure 2 ). At 12 months, overall, 28 eyes (97%) had stabilized VA. At 12 months, the BCVA in 15 eyes (52%) improved by 3 lines or more, and 13 eyes (45%) had stable VA ( Figure 3 ). The BCVA decreased in 1 eye (3%) because of massive subretinal hemorrhage 7 months after first combined therapy.

TABLE

Clinical Background and 12-Month Results of Combined Therapy in Patients

Patient No.	Age (yrs)	Gender	FA Findings	GLD (μm)	BCVA						Polyp	SRF	PED	Complications	No. of Treatments
					Baseline	1 Mos	3 Mos	6 Mos	9 Mos	12 Mos
1	72	M	Occ	3497	0.4	0.7	0.9	0.9	1.2	1.2	Di	Di	—	—	1
2	63	M	Occ	1362	0.5	0.5	0.7	0.7	0.9	0.9	Di	Di	—	—	1
3	78	M	PC	4378	0.05	0.2	0.6	0.2	0.7	1.2	Di	Di	—	—	2
4	78	F	PC	4401	0.05	0.02	0.05	0.06	0.06	0.1	Di	Di	—	—	1
5	72	M	Occ	4149	0.2	0.2	0.2	0.4	0.5	0.5	Di	—	—	—	1
6	63	M	Occ	2886	0.3	0.3	0.4	0.3	0.4	0.4	Di	Di	—	—	1
7	75	M	Occ	3175	0.2	0.8	0.8	0.7	0.6	0.9	Di	—	—	—	1
8	81	F	Occ	2558	0.3	0.4	0.4	0.5	0.8	0.9	Di	—	—	—	1
9	80	M	Occ	5465	0.2	0.2	0.4	0.4	0.4	0.3	Di	Di	—	—	1
10	71	M	Occ	3446	0.15	0.1	0.15	0.2	0.2	0.2	Di	Di	—	—	1
11	68	M	Occ	5661	0.15	0.2	0.2	0.3	0.3	0.3	Di	Di	—	—	1
12	73	M	Occ	2211	0.5	0.8	1.0	0.7	0.9	1.0	Re	Di	De	—	1
13	67	M	Occ	3498	0.1	0.2	0.4	0.5	0.5	0.2	Re	Di	—	—	3
14	72	F	Occ	5500	0.4	0.7	0.6	1.0	1.2	1.2	Di	Di	—	—	2
15	88	M	Occ	1442	0.5	0.5	0.8	0.9	1.0	1.0	Di	Di	De	—	1
16	64	M	Occ	5275	0.15	0.15	0.1	0.2	0.15	0.15	Di	Re	Re	Hemorrhage	3
17	77	M	Occ	3481	0.2	0.2	0.4	0.4	0.4	0.3	Re	Re	De	—	4
18	60	M	Occ	2742	0.7	0.6	0.5	0.6	0.7	0.8	Di	Di	—	—	2
19	69	M	Occ	2559	0.5	0.4	0.4	0.5	0.6	0.9	Di	Di	—	—	1
20	81	F	Occ	5416	0.3	0.3	0.4	0.4	0.5	0.6	Di	Di	—	—	1
21	64	M	Occ	2994	0.2	0.3	0.3	0.4	0.2	0.2	Di	Di	Re	—	2
22	77	M	Occ	4107	0.5	0.9	0.8	1.0	1.0	1.0	Di	Di	Di	Hemorrhage	2
23	84	F	Occ	4355	0.1	0.2	0.2	0.2	0.2	0.2	Di	Di	Di	—	1
24	77	M	Occ	5303	0.08	0.1	0.09	0.2	0.1	0.1	Di	—	Di	—	1
25	82	M	Occ	3153	0.3	0.4	0.4	0.3	0.04	0.04	Re	Di	Re	Massive hemorrhage	3
26	64	M	Occ	5400	0.4	0.3	0.6	0.6	0.6	0.6	Di	Di	Di	—	1
27	64	M	Occ	1835	0.2	0.6	1.0	1.2	1.0	0.9	Di	Di	—	—	1
28	79	F	Occ	3025	0.6	0.6	0.6	0.6	0.5	0.7	Di	Re	—	—	3
29	70	F	Occ	2414	0.5	0.6	0.8	1.0	0.9	0.9	Di	—	—	—	2
Average	73			3644	0.25	0.31	0.39	0.44	0.44	0.45					1.58

BCVA = best-corrected visual acuity; De = decreased; Di = disappeared; F = female; FA = fluorescein angiography; GLD = greatest linear dimension; M = male; Mos = months; NC = no change; Occ = occult choroidal neovascularization; PC = predominantly classic neovascularization; PED = pigment epithelial detachment; Polyp = polypoidal lesions by indocyanine green angiography; Re = recurred; SRF = subretinal fluid; yrs = years.

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