Original Paper
Ophthalmologica
Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
Received: March 20, 2017 Accepted after revision: July 27, 2017 Published online: September 13, 2017
Two-Year Outcomes of a Treat-and-Extend Regimen Using Intravitreal Aflibercept Injections for Typical Age-Related Macular Degeneration Arisa Ito Hidetaka Matsumoto Masahiro Morimoto Kensuke Mimura Hideo Akiyama Department of Ophthalmology, Gunma University School of Medicine, Gunma, Japan
Keywords Medical treatment of age-related macular degeneration · Anti-vascular endothelial growth factor · Choroidal neovascularization · Macula · Macular degeneration · Optical coherence tomography · Retina
BCVA and exudative changes. The exudation may be suppressed with fewer treatments in classic CNV compared to occult CNV. © 2017 S. Karger AG, Basel
Introduction
© 2017 S. Karger AG, Basel E-Mail [email protected] www.karger.com/oph
Age-related macular degeneration (AMD) is one of the main causes of acquired blindness in developed countries [1]. AMD is classified into atrophic and exudative AMD [2], and the latter is further classified into typical AMD (tAMD), polypoidal choroidal vasculopathy, and retinal angiomatous proliferation [3]. Choroidal neovascularization (CNV) is classified according to the Gass classification system into type 1 CNV and type 2 CNV, depending on the location of CNV [4]. Type 1 CNV occurs below the retinal pigment epithelium (RPE) and often manifests as occult CNV on performing fluorescein angiography. Meanwhile, type 2 CNV occurs above the RPE and often manifests as classic CNV on fluorescein angiography. Intravitreal injections of ranibizumab (IVR) were proven to be effective for improving and stabilizing visual acuity in exudative AMD in the MARINA and ANHidetaka Matsumoto, MD, PhD Department of Ophthalmology Gunma University School of Medicine 3-39-15 Showa-machi, Maebashi, Gunma 371-8511 (Japan) E-Mail hide-m @ gunma-u.ac.jp
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 10/16/2017 7:58:55 PM
Abstract Purpose: The aim of this study was to evaluate the efficacy of a treat-and-extend (TAE) regimen using intravitreal injection of aflibercept (IVA) for typical age-related macular degeneration (tAMD). Methods: We retrospectively studied 61 treatment-naïve eyes with tAMD. Best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), number of injections, and complications during 2 years were evaluated. Results: BCVA significantly improved by on average 0.13 logMAR units, and CMT and CCT significantly decreased after 2 years. The number of injections was on average 13.6. In the second year, eyes with classic choroidal neovascularization (CNV) needed significantly fewer treatments than eyes with occult CNV. Fourteen eyes, which developed subfoveal fibrosis, showed significantly poorer BCVA after 2 years. Subfoveal fibrosis was significantly common in classic CNV. Conclusion: A TAE regimen using IVA for tAMD might be effective for improving
tor, OH, USA), color fundus photography (CX-1; Canon, Tokyo, Japan), fluorescein angiography, indocyanine green angiography (Spectralis HRA + OCT; Heidelberg Engineering, Heidelberg, Germany), swept-source OCT (DRI OCT-1; Topcon Corp., Tokyo, Japan), or spectral-domain OCT (Cirrus OCT; Zeiss Meditec, Inc., Dublin, CA, USA). CNV classifications [16] were predominantly classic CNV in 17 eyes (27.9%), minimally classic CNV in 1 eye (1.6%), and occult CNV in 43 eyes (70.5%). The TAE regimen involved 3 monthly 2-mg IVA in the loading phase. This was followed by prolongation of the injection interval by 2 weeks if no exudative changes were seen or shortening of the injection interval by 2 weeks if exudative changes were seen in the maintenance phase. Exudative changes were defined as new hemorrhage detected by fundus examination or subretinal fluid or intraretinal edema detected by OCT. The minimum and maximum injection intervals were set at 4 and 12 weeks. Written informed consent for angiography and IVA was obtained from each patient. The endpoints were best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), number of intravitreal injections, and complications. These endpoints were retrospectively evaluated 2 years after starting treatment. CMT and CCT were measured using a measurement function included on B-scan OCT, which passes through the fovea. CMT was the distance from the internal limiting membrane to the RPE at the fovea, while CCT was the distance from Bruch’s membrane to the chorioscleral border under the fovea. The statistical analysis software used was Statcel4 [17], and paired or unpaired intergroup comparisons of BCVA, CMT, and CCT were performed using the Wilcoxon signed-rank test or Mann-Whitney U test. For intergroup comparisons by sex, the Fisher exact probability test was used. The Fisher exact probability test was also used to examine the relationship between the onset of subfoveal fibrosis and type of disease. BCVA was subject to statistical analysis after converting decimal visual acuity to logMAR values.
Results
Of 76 patients (77 eyes) who underwent a TAE regimen using intravitreal injections of aflibercept (IVA) for treatment-naïve tAMD at Gunma University Hospital between November 2013 and October 2014, we examined 60 patients (61 eyes; 47 men [48 eyes] and 13 women [13 eyes]) with a mean age of 73.1 (range: 57–90) years, who were able to continue the treatment for at least 2 years. Before treatment, all patients underwent a complete ophthalmic examination, including slit-lamp biomicroscopy with a noncontact fundus lens (SuperField lens; Volk Optical Inc., Men-
The clinical data of the patients before treatment are presented in Table 1. Compared with classic CNV (predominantly or minimally), occult CNV was mainly seen in male patients (p < 0.05). Pretreatment BCVA was significantly poorer in classic CNV than in occult CNV (p < 0.001), and pretreatment CMT was also significantly higher in classic CNV (p < 0.01). BCVA significantly improved from 0.37 ± 0.04 logMAR units (mean ± standard error) before treatment to 0.25 ± 0.04 after the loading phase (3 months after starting treatment; p < 0.001). BCVA was maintained at 0.21 ± 0.04 (p < 0.001) after 1 year and 0.23 ± 0.05 (p < 0.001) after 2 years. In classic CNV, BCVA significantly improved from 0.62 ± 0.08 before treatment to 0.50 ± 0.09 after the loading phase (p < 0.01) and was maintained at 0.43 ± 0.09 (p < 0.01) after 1 year and 0.45 ± 0.1 (p < 0.05)
Efficacy of Aflibercept Treat-and-Extend in Typical AMD
Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
Materials and Methods
237
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CHOR studies [5, 6], and intravitreal injections of antivascular endothelial growth factor (VEGF) agents have been the standard treatment for exudative AMD. The main anti-VEGF drugs currently used in the field of ophthalmology are bevacizumab, ranibizumab, and aflibercept. Bevacizumab and ranibizumab exert an antiangiogenic effect by inhibiting VEGF-A, whereas aflibercept exerts an antiangiogenic effect by inhibiting VEGF-B and placental growth factor in addition to VEGF-A [7]. Anti-VEGF agents are given at fixed intervals, such as monthly or bimonthly, and regimens include reactive pro re nata (PRN) regimens and proactive treat-and-extend (TAE) regimens. The MARINA and ANCHOR studies [5, 6] required monthly appointments and injections. Treatment methods with fewer appointments and injections have, therefore, been explored in the light of the burden on patients and medical expenditure. The PIER and EXCITE studies [8, 9] showed that a fixed regimen using 1 injection every 3 months following 3 monthly injections did not achieve a comparable therapeutic effect to a monthly regimen. Meanwhile, the PrONTO study [10] showed that a PRN regimen based on optical coherence tomography (OCT) findings had a comparable therapeutic effect to a monthly regimen; however, such a regimen still requires monthly appointments. TAE, a regimen first proposed and coined by Spaide [11], is currently the predominant treatment method. Rayess et al. [12] reported improved and maintained visual acuity for up to 3 years after starting treatment with a TAE regimen using bevacizumab or ranibizumab for exudative AMD. There are a number of reports on the therapeutic outcomes of aflibercept for exudative AMD, for example on bimonthly regimens [13] and the effects of switching to aflibercept in patients who respond poorly to ranibizumab [14]. However, reports on the therapeutic outcomes of TAE with aflibercept for treatment-naïve exudative AMD are rare [15]. Here, we report the 2-year outcomes of a TAE regimen using aflibercept for tAMD.
Table 1. Clinical findings of the patients with typical AMD at baseline
Typical AMD
CNV classification classic CNV
Eyes, n (%) Patients, n (%) Male Female Age, years Mean ± SE Range BCVA, logMAR Mean ± SE Median Range CMT, μm Mean ± SE Median Range CCT, μm Mean ± SE Median Range
occult CNV
p value*
61 (100)
18 (29.5)
43 (70.5)
47 (78.3) 13 (21.7)
11 (61.1) 7 (38.9)
37 (86.0) 6 (14.0)
0.03
73.1 ± 1.08 57 to 90
75.6 ± 1.73 63 to 84
72.0 ± 1.32 57 to 90
0.09
0.37 ± 0.04 0.30 –0.079 to 1.22
0.62 ± 0.08 0.69 0 to 1.09
0.26 ± 0.05 0.096 –0.079 to 1.22
0.0006
338 ± 19 312 108 to 855
428 ± 43 412 184 to 855
301 ± 18 279 108 to 606
0.009
241 ± 14 216 52 to 491
215 ± 25 193 54 to 398
252 ± 16 221 52 to 491
0.26
AMD, age-related macular degeneration; CNV, choroidal neovascularization; SE, standard error; BCVA, best-corrected visual acuity; CMT, central macular thickness; CCT, central choroidal thickness. * p value indicates the statistical significance of difference between the CNV classifications.
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Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
after the loading phase (p < 0.001). CCT was maintained at 205 ± 12 μm (p < 0.001) after 1 year and 199 ± 12 μm (p < 0.001) after 2 years. In classic CNV, CCT significantly decreased from 215 ± 25 μm before treatment to 177 ± 21 μm after the loading phase (p < 0.001) and was maintained at 175 ± 21 μm (p < 0.001) after 1 year and 171 ± 22 μm (p < 0.001) after 2 years. In occult CNV, CCT also decreased significantly from 252 ± 16 μm before treatment to 215 ± 16 μm after the loading phase (p < 0.001) and was maintained at 217 ± 15 μm (p < 0.001) after 1 year and 210 ± 14 μm (p < 0.001) after 2 years (Table 2; Fig. 3). The number of injections was 8.1 ± 0.2 (mean ± standard error) in the first year and 5.4 ± 0.2 in the second year. In classic CNV, the number of injections was 7.7 ± 0.3 in the first year and 4.6 ± 0.2 in the second year. In occult CNV, the number of injections was 8.3 ± 0.3 in the first year and 5.8 ± 0.3 in the second year. The number of injections did not significantly differ between the 2 groups in the first year but was significantly lower in the classic CNV group in the second year (p < 0.01). In 9 eyes with classic CNV (50%) and 9 eyes with occult CNV (20.9%), the exudative change did not recur after the loading Ito/Matsumoto/Morimoto/Mimura/ Akiyama
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after 2 years. In occult CNV, BCVA also significantly improved from 0.26 ± 0.05 before treatment to 0.15 ± 0.04 after the loading phase (p < 0.001) and was maintained at 0.12 ± 0.04 (p < 0.001) after 1 year and 0.14 ± 0.05 (p < 0.01) after 2 years. BCVA gains for 2 years did not differ between classic CNV (–0.17 ± 0.06) and occult CNV (–0.12 ± 0.05) (Table 2; Fig. 1). CMT significantly decreased from 338 ± 19 μm (mean ± standard error) before treatment to 179 ± 10 μm after the loading phase (p < 0.001). CMT was maintained at 171 ± 7 μm (p < 0.001) after 1 year and 173 ± 8 μm (p < 0.001) after 2 years. In classic CNV, CMT significantly decreased from 428 ± 43 μm before treatment to 199 ± 22 μm after the loading phase (p < 0.001) and was maintained at 174 ± 13 μm (p < 0.001) after 1 year and 162 ± 12 μm (p < 0.001) after 2 years. In occult CNV, CMT also significantly decreased from 301 ± 18 μm before treatment to 171 ± 11 μm after the loading phase (p < 0.001) and was maintained at 169 ± 9 μm (p < 0.001) after 1 year and 177 ± 10 μm (p < 0.001) after 2 years (Table 2; Fig. 2). CCT also significantly decreased from 241 ± 14 μm (mean ± standard error) before treatment to 204 ± 13 μm
Table 2. Changes in visual acuity, CMT, and CCT in typical AMD
Typical AMD (n = 61) BCVA, logMAR CMT, μm CCT, μm Classic CNV (n = 18) BCVA, logMAR CMT, μm CCT, μm Occult CNV (n = 43) BCVA, logMAR CMT, μm CCT, μm
Baseline
3 months
12 months
24 months
Difference between baseline and 24 months
p value*
0.37 ± 0.04 338 ± 19 241 ± 14
0.25 ± 0.04 179 ± 10 204 ± 13
0.21 ± 0.04 171 ± 7 205 ± 12
0.23 ± 0.05 173 ± 8 199 ± 12
–0.13 ± 0.04 –165 ± 21 –42 ± 4
Ophthalmologica
Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
Received: March 20, 2017 Accepted after revision: July 27, 2017 Published online: September 13, 2017
Two-Year Outcomes of a Treat-and-Extend Regimen Using Intravitreal Aflibercept Injections for Typical Age-Related Macular Degeneration Arisa Ito Hidetaka Matsumoto Masahiro Morimoto Kensuke Mimura Hideo Akiyama Department of Ophthalmology, Gunma University School of Medicine, Gunma, Japan
Keywords Medical treatment of age-related macular degeneration · Anti-vascular endothelial growth factor · Choroidal neovascularization · Macula · Macular degeneration · Optical coherence tomography · Retina
BCVA and exudative changes. The exudation may be suppressed with fewer treatments in classic CNV compared to occult CNV. © 2017 S. Karger AG, Basel
Introduction
© 2017 S. Karger AG, Basel E-Mail [email protected] www.karger.com/oph
Age-related macular degeneration (AMD) is one of the main causes of acquired blindness in developed countries [1]. AMD is classified into atrophic and exudative AMD [2], and the latter is further classified into typical AMD (tAMD), polypoidal choroidal vasculopathy, and retinal angiomatous proliferation [3]. Choroidal neovascularization (CNV) is classified according to the Gass classification system into type 1 CNV and type 2 CNV, depending on the location of CNV [4]. Type 1 CNV occurs below the retinal pigment epithelium (RPE) and often manifests as occult CNV on performing fluorescein angiography. Meanwhile, type 2 CNV occurs above the RPE and often manifests as classic CNV on fluorescein angiography. Intravitreal injections of ranibizumab (IVR) were proven to be effective for improving and stabilizing visual acuity in exudative AMD in the MARINA and ANHidetaka Matsumoto, MD, PhD Department of Ophthalmology Gunma University School of Medicine 3-39-15 Showa-machi, Maebashi, Gunma 371-8511 (Japan) E-Mail hide-m @ gunma-u.ac.jp
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 10/16/2017 7:58:55 PM
Abstract Purpose: The aim of this study was to evaluate the efficacy of a treat-and-extend (TAE) regimen using intravitreal injection of aflibercept (IVA) for typical age-related macular degeneration (tAMD). Methods: We retrospectively studied 61 treatment-naïve eyes with tAMD. Best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), number of injections, and complications during 2 years were evaluated. Results: BCVA significantly improved by on average 0.13 logMAR units, and CMT and CCT significantly decreased after 2 years. The number of injections was on average 13.6. In the second year, eyes with classic choroidal neovascularization (CNV) needed significantly fewer treatments than eyes with occult CNV. Fourteen eyes, which developed subfoveal fibrosis, showed significantly poorer BCVA after 2 years. Subfoveal fibrosis was significantly common in classic CNV. Conclusion: A TAE regimen using IVA for tAMD might be effective for improving
tor, OH, USA), color fundus photography (CX-1; Canon, Tokyo, Japan), fluorescein angiography, indocyanine green angiography (Spectralis HRA + OCT; Heidelberg Engineering, Heidelberg, Germany), swept-source OCT (DRI OCT-1; Topcon Corp., Tokyo, Japan), or spectral-domain OCT (Cirrus OCT; Zeiss Meditec, Inc., Dublin, CA, USA). CNV classifications [16] were predominantly classic CNV in 17 eyes (27.9%), minimally classic CNV in 1 eye (1.6%), and occult CNV in 43 eyes (70.5%). The TAE regimen involved 3 monthly 2-mg IVA in the loading phase. This was followed by prolongation of the injection interval by 2 weeks if no exudative changes were seen or shortening of the injection interval by 2 weeks if exudative changes were seen in the maintenance phase. Exudative changes were defined as new hemorrhage detected by fundus examination or subretinal fluid or intraretinal edema detected by OCT. The minimum and maximum injection intervals were set at 4 and 12 weeks. Written informed consent for angiography and IVA was obtained from each patient. The endpoints were best-corrected visual acuity (BCVA), central macular thickness (CMT), central choroidal thickness (CCT), number of intravitreal injections, and complications. These endpoints were retrospectively evaluated 2 years after starting treatment. CMT and CCT were measured using a measurement function included on B-scan OCT, which passes through the fovea. CMT was the distance from the internal limiting membrane to the RPE at the fovea, while CCT was the distance from Bruch’s membrane to the chorioscleral border under the fovea. The statistical analysis software used was Statcel4 [17], and paired or unpaired intergroup comparisons of BCVA, CMT, and CCT were performed using the Wilcoxon signed-rank test or Mann-Whitney U test. For intergroup comparisons by sex, the Fisher exact probability test was used. The Fisher exact probability test was also used to examine the relationship between the onset of subfoveal fibrosis and type of disease. BCVA was subject to statistical analysis after converting decimal visual acuity to logMAR values.
Results
Of 76 patients (77 eyes) who underwent a TAE regimen using intravitreal injections of aflibercept (IVA) for treatment-naïve tAMD at Gunma University Hospital between November 2013 and October 2014, we examined 60 patients (61 eyes; 47 men [48 eyes] and 13 women [13 eyes]) with a mean age of 73.1 (range: 57–90) years, who were able to continue the treatment for at least 2 years. Before treatment, all patients underwent a complete ophthalmic examination, including slit-lamp biomicroscopy with a noncontact fundus lens (SuperField lens; Volk Optical Inc., Men-
The clinical data of the patients before treatment are presented in Table 1. Compared with classic CNV (predominantly or minimally), occult CNV was mainly seen in male patients (p < 0.05). Pretreatment BCVA was significantly poorer in classic CNV than in occult CNV (p < 0.001), and pretreatment CMT was also significantly higher in classic CNV (p < 0.01). BCVA significantly improved from 0.37 ± 0.04 logMAR units (mean ± standard error) before treatment to 0.25 ± 0.04 after the loading phase (3 months after starting treatment; p < 0.001). BCVA was maintained at 0.21 ± 0.04 (p < 0.001) after 1 year and 0.23 ± 0.05 (p < 0.001) after 2 years. In classic CNV, BCVA significantly improved from 0.62 ± 0.08 before treatment to 0.50 ± 0.09 after the loading phase (p < 0.01) and was maintained at 0.43 ± 0.09 (p < 0.01) after 1 year and 0.45 ± 0.1 (p < 0.05)
Efficacy of Aflibercept Treat-and-Extend in Typical AMD
Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
Materials and Methods
237
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 10/16/2017 7:58:55 PM
CHOR studies [5, 6], and intravitreal injections of antivascular endothelial growth factor (VEGF) agents have been the standard treatment for exudative AMD. The main anti-VEGF drugs currently used in the field of ophthalmology are bevacizumab, ranibizumab, and aflibercept. Bevacizumab and ranibizumab exert an antiangiogenic effect by inhibiting VEGF-A, whereas aflibercept exerts an antiangiogenic effect by inhibiting VEGF-B and placental growth factor in addition to VEGF-A [7]. Anti-VEGF agents are given at fixed intervals, such as monthly or bimonthly, and regimens include reactive pro re nata (PRN) regimens and proactive treat-and-extend (TAE) regimens. The MARINA and ANCHOR studies [5, 6] required monthly appointments and injections. Treatment methods with fewer appointments and injections have, therefore, been explored in the light of the burden on patients and medical expenditure. The PIER and EXCITE studies [8, 9] showed that a fixed regimen using 1 injection every 3 months following 3 monthly injections did not achieve a comparable therapeutic effect to a monthly regimen. Meanwhile, the PrONTO study [10] showed that a PRN regimen based on optical coherence tomography (OCT) findings had a comparable therapeutic effect to a monthly regimen; however, such a regimen still requires monthly appointments. TAE, a regimen first proposed and coined by Spaide [11], is currently the predominant treatment method. Rayess et al. [12] reported improved and maintained visual acuity for up to 3 years after starting treatment with a TAE regimen using bevacizumab or ranibizumab for exudative AMD. There are a number of reports on the therapeutic outcomes of aflibercept for exudative AMD, for example on bimonthly regimens [13] and the effects of switching to aflibercept in patients who respond poorly to ranibizumab [14]. However, reports on the therapeutic outcomes of TAE with aflibercept for treatment-naïve exudative AMD are rare [15]. Here, we report the 2-year outcomes of a TAE regimen using aflibercept for tAMD.
Table 1. Clinical findings of the patients with typical AMD at baseline
Typical AMD
CNV classification classic CNV
Eyes, n (%) Patients, n (%) Male Female Age, years Mean ± SE Range BCVA, logMAR Mean ± SE Median Range CMT, μm Mean ± SE Median Range CCT, μm Mean ± SE Median Range
occult CNV
p value*
61 (100)
18 (29.5)
43 (70.5)
47 (78.3) 13 (21.7)
11 (61.1) 7 (38.9)
37 (86.0) 6 (14.0)
0.03
73.1 ± 1.08 57 to 90
75.6 ± 1.73 63 to 84
72.0 ± 1.32 57 to 90
0.09
0.37 ± 0.04 0.30 –0.079 to 1.22
0.62 ± 0.08 0.69 0 to 1.09
0.26 ± 0.05 0.096 –0.079 to 1.22
0.0006
338 ± 19 312 108 to 855
428 ± 43 412 184 to 855
301 ± 18 279 108 to 606
0.009
241 ± 14 216 52 to 491
215 ± 25 193 54 to 398
252 ± 16 221 52 to 491
0.26
AMD, age-related macular degeneration; CNV, choroidal neovascularization; SE, standard error; BCVA, best-corrected visual acuity; CMT, central macular thickness; CCT, central choroidal thickness. * p value indicates the statistical significance of difference between the CNV classifications.
238
Ophthalmologica 2017;238:236–242 DOI: 10.1159/000479937
after the loading phase (p < 0.001). CCT was maintained at 205 ± 12 μm (p < 0.001) after 1 year and 199 ± 12 μm (p < 0.001) after 2 years. In classic CNV, CCT significantly decreased from 215 ± 25 μm before treatment to 177 ± 21 μm after the loading phase (p < 0.001) and was maintained at 175 ± 21 μm (p < 0.001) after 1 year and 171 ± 22 μm (p < 0.001) after 2 years. In occult CNV, CCT also decreased significantly from 252 ± 16 μm before treatment to 215 ± 16 μm after the loading phase (p < 0.001) and was maintained at 217 ± 15 μm (p < 0.001) after 1 year and 210 ± 14 μm (p < 0.001) after 2 years (Table 2; Fig. 3). The number of injections was 8.1 ± 0.2 (mean ± standard error) in the first year and 5.4 ± 0.2 in the second year. In classic CNV, the number of injections was 7.7 ± 0.3 in the first year and 4.6 ± 0.2 in the second year. In occult CNV, the number of injections was 8.3 ± 0.3 in the first year and 5.8 ± 0.3 in the second year. The number of injections did not significantly differ between the 2 groups in the first year but was significantly lower in the classic CNV group in the second year (p < 0.01). In 9 eyes with classic CNV (50%) and 9 eyes with occult CNV (20.9%), the exudative change did not recur after the loading Ito/Matsumoto/Morimoto/Mimura/ Akiyama
Downloaded by: Univ. of California Santa Barbara 128.111.121.42 - 10/16/2017 7:58:55 PM
after 2 years. In occult CNV, BCVA also significantly improved from 0.26 ± 0.05 before treatment to 0.15 ± 0.04 after the loading phase (p < 0.001) and was maintained at 0.12 ± 0.04 (p < 0.001) after 1 year and 0.14 ± 0.05 (p < 0.01) after 2 years. BCVA gains for 2 years did not differ between classic CNV (–0.17 ± 0.06) and occult CNV (–0.12 ± 0.05) (Table 2; Fig. 1). CMT significantly decreased from 338 ± 19 μm (mean ± standard error) before treatment to 179 ± 10 μm after the loading phase (p < 0.001). CMT was maintained at 171 ± 7 μm (p < 0.001) after 1 year and 173 ± 8 μm (p < 0.001) after 2 years. In classic CNV, CMT significantly decreased from 428 ± 43 μm before treatment to 199 ± 22 μm after the loading phase (p < 0.001) and was maintained at 174 ± 13 μm (p < 0.001) after 1 year and 162 ± 12 μm (p < 0.001) after 2 years. In occult CNV, CMT also significantly decreased from 301 ± 18 μm before treatment to 171 ± 11 μm after the loading phase (p < 0.001) and was maintained at 169 ± 9 μm (p < 0.001) after 1 year and 177 ± 10 μm (p < 0.001) after 2 years (Table 2; Fig. 2). CCT also significantly decreased from 241 ± 14 μm (mean ± standard error) before treatment to 204 ± 13 μm
Table 2. Changes in visual acuity, CMT, and CCT in typical AMD
Typical AMD (n = 61) BCVA, logMAR CMT, μm CCT, μm Classic CNV (n = 18) BCVA, logMAR CMT, μm CCT, μm Occult CNV (n = 43) BCVA, logMAR CMT, μm CCT, μm
Baseline
3 months
12 months
24 months
Difference between baseline and 24 months
p value*
0.37 ± 0.04 338 ± 19 241 ± 14
0.25 ± 0.04 179 ± 10 204 ± 13
0.21 ± 0.04 171 ± 7 205 ± 12
0.23 ± 0.05 173 ± 8 199 ± 12
–0.13 ± 0.04 –165 ± 21 –42 ± 4
