Driving Ability Reported by Neovascular Age-related Macular Degeneration Patients after Treatment with Ranibizumab
Objectives To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD). Design Phase III, multicenter, randomized clinical trials (Minimally...
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Published in | Ophthalmology (Rochester, Minn.) Vol. 120; no. 1; pp. 160 - 168 |
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Main Authors | , , , , , , , , |
Format | Journal Article |
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2013
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Abstract | Objectives To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD). Design Phase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]). Participants One thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD. Methods Participants were assigned randomly to sham (n = 238), 0.3-mg ranibizumab monthly injections (n = 238), or 0.5-mg ranibizumab monthly injections (n = 240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n = 143), 0.3-mg ranibizumab monthly injections (n = 140), or 0.5-mg ranibizumab monthly injections (n = 140) for 24 months (ANCHOR). Main Outcome Measures Self-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months. Results At baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2–75.2) of sham patients and 78.4% (95% CI, 71.8–85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8–82.4) of PDT patients and 91.4% (95% CI, 85.3–97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months ( R2 = 0.17 and R2 = 0.20 at 12 and 24 months, respectively [ P <0.001], in the MARINA trial; R2 = 0.13 and R2 = 0.14, respectively [ P <0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups. Conclusions These results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references. |
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AbstractList | Objectives To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD). Design Phase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]). Participants One thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD. Methods Participants were assigned randomly to sham (n = 238), 0.3-mg ranibizumab monthly injections (n = 238), or 0.5-mg ranibizumab monthly injections (n = 240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n = 143), 0.3-mg ranibizumab monthly injections (n = 140), or 0.5-mg ranibizumab monthly injections (n = 140) for 24 months (ANCHOR). Main Outcome Measures Self-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months. Results At baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2–75.2) of sham patients and 78.4% (95% CI, 71.8–85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8–82.4) of PDT patients and 91.4% (95% CI, 85.3–97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months ( R2 = 0.17 and R2 = 0.20 at 12 and 24 months, respectively [ P <0.001], in the MARINA trial; R2 = 0.13 and R2 = 0.14, respectively [ P <0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups. Conclusions These results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT. Financial Disclosure(s) Proprietary or commercial disclosure may be found after the references. To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD). Phase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]). One thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD. Participants were assigned randomly to sham (n=238), 0.3-mg ranibizumab monthly injections (n=238), or 0.5-mg ranibizumab monthly injections (n=240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n=143), 0.3-mg ranibizumab monthly injections (n=140), or 0.5-mg ranibizumab monthly injections (n=140) for 24 months (ANCHOR). Self-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months. At baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2-75.2) of sham patients and 78.4% (95% CI, 71.8-85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8-82.4) of PDT patients and 91.4% (95% CI, 85.3-97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months (R2=0.17 and R2=0.20 at 12 and 24 months, respectively [P<0.001], in the MARINA trial; R2=0.13 and R2=0.14, respectively [P<0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups. These results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT. Proprietary or commercial disclosure may be found after the references. OBJECTIVESTo determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal neovascularization resulting from age-related macular degeneration (AMD).DESIGNPhase III, multicenter, randomized clinical trials (Minimally Classic/Occult Trial of the Anti-VEGF Antibody Ranibizumab in the Treatment of Neovascular Age-Related Macular Degeneration [MARINA] and Anti-VEGF Antibody for the Treatment of Predominantly Classic Choroidal Neovascularization in Age-Related Macular Degeneration [ANCHOR]).PARTICIPANTSOne thousand one hundred twenty-six patients with choroidal neovascularization resulting from AMD.METHODSParticipants were assigned randomly to sham (n=238), 0.3-mg ranibizumab monthly injections (n=238), or 0.5-mg ranibizumab monthly injections (n=240) for 24 months (MARINA), or were randomized to verteporfin photodynamic therapy (PDT; n=143), 0.3-mg ranibizumab monthly injections (n=140), or 0.5-mg ranibizumab monthly injections (n=140) for 24 months (ANCHOR).MAIN OUTCOME MEASURESSelf-reported driving status and driving ability perception were assessed as exploratory outcomes at baseline through 24 months after baseline using the 25-item National Eye Institute Visual Function Questionnaire. Best-corrected visual acuity in each eye was assessed monthly through 24 months.RESULTSAt baseline, 68.6% of patients in the MARINA trial and 62.7% of patients in the ANCHOR trial reported driving. Among patients driving at baseline in the MARINA trial 2 years after randomization, 67.2% (95% confidence interval [CI], 59.2-75.2) of sham patients and 78.4% (95% CI, 71.8-85.0) of 0.5-mg patients reported that they were still driving. Among patients driving at baseline in the ANCHOR trial at 2 years after randomization, 71.6% (95% CI, 60.8-82.4) of PDT patients and 91.4% (95% CI, 85.3-97.5) of 0.5-mg patients were still driving. Also in the ANCHOR trial, ranibizumab-treated patients who were not driving at baseline seemed more likely to drive by months 12 and 24 than PDT patients. Perception of driving ability was correlated with improvement in visual acuity (VA) in the better-seeing eye at 12 and 24 months (R2=0.17 and R2=0.20 at 12 and 24 months, respectively [P<0.001], in the MARINA trial; R2=0.13 and R2=0.14, respectively [P<0.001], in the ANCHOR trial). Visual acuity in one or both eyes 2 years after randomization was more likely to be 20/40 or better in the ranibizumab-treated groups.CONCLUSIONSThese results suggest that patients with neovascular AMD treated with ranibizumab are more likely to report driving ability and have vision of at least 20/40 than patients given sham treatment or PDT.FINANCIAL DISCLOSURE(S)Proprietary or commercial disclosure may be found after the references. |
Author | Bressler, Neil M., MD Chang, Tom S., MD Varma, Rohit, MD Suñer, Ivan, MD Lee, Paul, MD Ward, James, PhD Dolan, Chantal M., PhD Ianchulev, Tsontcho, MD, MPH Fine, Jennifer, ScD |
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BackLink | https://www.ncbi.nlm.nih.gov/pubmed/23009891$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1136_bmjopen_2022_065210 crossref_primary_10_1111_aos_14731 crossref_primary_10_1001_jama_2022_6381 crossref_primary_10_1016_S2214_109X_20_30488_5 crossref_primary_10_1016_j_oret_2023_10_010 crossref_primary_10_1016_j_ophtha_2013_09_042 crossref_primary_10_1016_j_ophtha_2013_11_022 crossref_primary_10_1097_IAE_0000000000000664 crossref_primary_10_1016_j_survophthal_2016_12_011 crossref_primary_10_3390_jcm11133627 crossref_primary_10_1016_j_oret_2018_11_004 crossref_primary_10_3390_jcm10214845 crossref_primary_10_1002_14651858_CD005139_pub3 crossref_primary_10_1007_s40266_013_0077_9 crossref_primary_10_1002_14651858_CD005139_pub4 crossref_primary_10_1016_j_ophtha_2017_12_034 |
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Snippet | Objectives To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal... To determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal... OBJECTIVESTo determine the impact of ranibizumab on driving status, driving ability perception, and having 20/40 vision or better in patients with choroidal... |
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SubjectTerms | Aged Aged, 80 and over Angiogenesis Inhibitors - therapeutic use Antibodies, Monoclonal, Humanized - therapeutic use Automobile Driving - statistics & numerical data Combined Modality Therapy Double-Blind Method Female Humans Intravitreal Injections Male Middle Aged Ophthalmology Photochemotherapy Photosensitizing Agents - therapeutic use Porphyrins - therapeutic use Ranibizumab Self Report Sickness Impact Profile Vision, Low - physiopathology Vision, Low - rehabilitation Visual Acuity - physiology Wet Macular Degeneration - drug therapy Wet Macular Degeneration - physiopathology |
Title | Driving Ability Reported by Neovascular Age-related Macular Degeneration Patients after Treatment with Ranibizumab |
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