Purpose
To evaluate the efficacy of 1 intravitreal injection of ranibizumab monthly for 3 months in eyes with polypoidal choroidal vasculopathy (PCV), with attention to changes on indocyanine green angiography (ICGA) with confocal scanning laser ophthalmoscopy (cSLO).
Design
Prospective, consecutive case series.
Methods
Fifty consecutive eyes of 50 patients with symptomatic PCV who had not been treated previously received 1 intravitreal injection of 0.5 mg ranibizumab monthly for 3 months. Changes in ICGA findings with cSLO 3 months after the primary injection were evaluated.
Results
The mean visual acuity (VA) at baseline (0.25; range, 0.1-0.8) improved to 0.38 ( P = .001) 3 months after the primary injection. Nineteen eyes (38%) had an improvement in VA of 0.3 or more logMAR unit, and 5 eyes (10%) had a decrease in VA of 0.3 or more logMAR unit. Polypoidal lesions disappeared on ICGA in 13 eyes (26%) and the number of lesions decreased but did not disappear in 26 eyes (52%), with absorption of the accompanying fluid on optical coherence tomography. The remaining 11 eyes (22%) had unchanged or worsened polypoidal lesions. A branching vascular network remained in all 48 eyes in which the network was detected at baseline. Although resolution of the branching vascular networks or decreased diameter of the branching vascular network occurred in 11 eyes (23%), the branching vascular network was unchanged or worse in 37 eyes (77%).
Conclusion
Although a limitation of this study is the short-term follow-up, polypoidal lesions tended to respond to ranibizumab therapy, but the branching vascular network responded poorly.
Polypoidal choroidal vasculopathy (PCV), a distinct exudative macular disorder that is clinically relevant, is characterized by a network of vessels with 2 distinct components: a complex of branching vessels and multiple, terminal, reddish-orange, polypoidal lesions. 1 The polypoidal vascular abnormality may have an inactive or quiescent component and an active portion that accounts for the serosanguinous manifestations. PCV lesions appear as occult or minimally classic choroidal neovascularization on fluorescein angiography, while there is a clear polyp-like vascular network within the choroid on ICGA. Therefore, ICGA is essential for diagnosing PCV and identifying active components. Photodynamic therapy (PDT) PCV maintains or improves vision. Although in most eyes with PCV the polypoidal lesions initially resolve after PDT, indocyanine green angiography (ICGA) has shown that the branching vascular networks persist in most eyes. Recurrent or new polypoidal lesions develop at the terminal branching vascular network during the follow-up period, resulting in visual deterioration. After the MARINA and ANCHOR trials showed that monthly ranibizumab (Lucentis, Genentech, South San Francisco, California, USA) intravitreal injections were superior to PDT with verteporfin monotherapy and resulted in better visual outcomes and low rates of serious ocular adverse events in exudative age-related macular degeneration (AMD), ranibizumab has become the standard therapy for exudative AMD. Kokame and associates recently reported that continuous monthly intravitreal ranibizumab injections were safe and well tolerated and stabilized vision in eyes with PCV. In the current study, we evaluated the efficacy of 1 intravitreal injection of ranibizumab (0.5 mg) monthly for 3 months in eyes with PCV, with particular attention to the changes on ICGA with confocal scanning laser ophthalmoscopy (cSLO).
Patients and Methods
The study was a prospective, consecutive case series. Fifty consecutive eyes of 50 patients with PCV who had progressive visual symptoms and had not undergone previous treatments received 1 intravitreal injection of 0.5 mg ranibizumab monthly for 3 months at Ohtsuka Eye Hospital. The institutional review board approved the study protocol. PCV was diagnosed based on the fundus findings, ICGA findings, or both. Diagnosis met at least 1 of the following criteria: the presence of elevated orange-red lesions (excluding a pigment epithelial detachment, choroidal hemangioma, and subretinal blood) observed by fundus examination or characteristic polypoidal lesions on ICGA.
At baseline all eyes had a complete ophthalmic examination including visual acuity (VA) measurements with the ETDRS chart, digital simultaneous fluorescein angiography (FA) and ICGA using cSLO (HRA-2, Heidelberg Engineering Inc, Dossenheim, Germany), and optical coherence tomography (OCT) (OCT 3000, Zeiss Humphrey Instruments, Dublin, California, USA). Ophthalmic examinations including VA measurement and OCT were performed monthly. Digital simultaneous FA and ICGA using cSLO also were performed 3 months after the primary ranibizumab injection.
The differences in VAs between baseline and 3 months after the primary injection were analyzed using the paired Student t test. The logarithm of minimal angle of resolution (logMAR) was used to analyze the VA. Statistical analysis was performed using the SPSS 11.5.1 for Windows software package (SPSS Inc, Chicago, Illinois, USA). P < .05 was considered significant.
Results
Fifty patients (37 men, 13 women) were included. The mean (± standard deviation [SD]) patient age was 72 ± 8 years (range, 50-82 years). The mean baseline VA was 0.25 (range, 0.1-0.8) and improved to 0.38 ( P = .001) 3 months after the primary injection. Of the 50 eyes, 19 (38%) had an improvement in VA of 0.3 or more logMAR unit, 5 (10%) had a decrease in VA of 0.3 or more logMAR, and 26 (52%) had stable VA.
At baseline, ICGA detected polypoidal lesions in all 50 eyes; a branching vascular network also was detected in 48 (96%) eyes. In the remaining 2 (4%) eyes, a retinal and subretinal hemorrhage obscured a possible branching vascular network. OCT showed a steep, protruding retinal pigment epithelium (RPE) corresponding to the polypoidal lesions in all eyes. OCT also showed subretinal fluid (SRF) in 46 eyes (92%), a serous and/or hemorrhagic pigment epithelial detachment (PED) in 23 eyes (46%), and cystoid macular edema (CME) in 3 eyes (6%). Fibrin deposits were suspected in 8 eyes (16%). Thirty-four eyes (68%) had multiple polypoidal lesions; 16 (32%) had 1 lesion.
One month after the third intravitreal injection of ranibizumab, the polypoidal lesions disappeared on ICGA in 13 eyes (26%) and decreased but did not resolve in 26 eyes (52%) with absorption of the accompanying fluid ( Figures 1 and 2 ) . In the remaining 11 eyes (22%), the polypoidal lesions were unchanged or worse ( Figure 3 ). The branching vascular network remained in all 48 eyes in which it was detected at baseline. Although the small diameter of the branching vascular network disappeared or decreased in 11 eyes (23%) ( Figure 4 ), the branching vascular networks were unchanged or worse in 37 eyes (77%) ( Figures 1, 2, and 3 ). The baseline age, VA, and the number of polypoidal lesions did not affect the changes in the angiographic findings, but small polypoidal lesions, the sizes of which were about the diameter of the first branching retinal veins, tended to improve after treatment. The mean VA did not differ ( P = .844) 1 month after the third intravitreal injection of ranibizumab between eyes in which the polypoidal lesions improved and those in which they did not. No adverse events occurred during the follow-up period.
OCT showed resolution of the SRF in 30 of 46 eyes (65%) with initial SRF and decreased SRF in the remaining 16 eyes (35%). Serous and/or hemorrhagic PED resolved in 5 of 23 eyes (22%), decreased in 11 eyes (48%), and remained stable in 7 eyes (30%). The CME resolved in all 3 eyes. The subretinal hemorrhages resolved in 13 of 23 eyes (57%) and decreased in the remaining 10 eyes (43%).
Results
Fifty patients (37 men, 13 women) were included. The mean (± standard deviation [SD]) patient age was 72 ± 8 years (range, 50-82 years). The mean baseline VA was 0.25 (range, 0.1-0.8) and improved to 0.38 ( P = .001) 3 months after the primary injection. Of the 50 eyes, 19 (38%) had an improvement in VA of 0.3 or more logMAR unit, 5 (10%) had a decrease in VA of 0.3 or more logMAR, and 26 (52%) had stable VA.
At baseline, ICGA detected polypoidal lesions in all 50 eyes; a branching vascular network also was detected in 48 (96%) eyes. In the remaining 2 (4%) eyes, a retinal and subretinal hemorrhage obscured a possible branching vascular network. OCT showed a steep, protruding retinal pigment epithelium (RPE) corresponding to the polypoidal lesions in all eyes. OCT also showed subretinal fluid (SRF) in 46 eyes (92%), a serous and/or hemorrhagic pigment epithelial detachment (PED) in 23 eyes (46%), and cystoid macular edema (CME) in 3 eyes (6%). Fibrin deposits were suspected in 8 eyes (16%). Thirty-four eyes (68%) had multiple polypoidal lesions; 16 (32%) had 1 lesion.
One month after the third intravitreal injection of ranibizumab, the polypoidal lesions disappeared on ICGA in 13 eyes (26%) and decreased but did not resolve in 26 eyes (52%) with absorption of the accompanying fluid ( Figures 1 and 2 ) . In the remaining 11 eyes (22%), the polypoidal lesions were unchanged or worse ( Figure 3 ). The branching vascular network remained in all 48 eyes in which it was detected at baseline. Although the small diameter of the branching vascular network disappeared or decreased in 11 eyes (23%) ( Figure 4 ), the branching vascular networks were unchanged or worse in 37 eyes (77%) ( Figures 1, 2, and 3 ). The baseline age, VA, and the number of polypoidal lesions did not affect the changes in the angiographic findings, but small polypoidal lesions, the sizes of which were about the diameter of the first branching retinal veins, tended to improve after treatment. The mean VA did not differ ( P = .844) 1 month after the third intravitreal injection of ranibizumab between eyes in which the polypoidal lesions improved and those in which they did not. No adverse events occurred during the follow-up period.
