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Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration.
JAMA Ophthalmol 2016; 134(5):545-553JO

Abstract

IMPORTANCE

Understanding the range of temporal responses to ranibizumab is critical for the assessment of individualized treatment regimens for neovascular age-related macular degeneration.

OBJECTIVE

To examine patterns of visual and anatomical response to ranibizumab treatment.

DESIGN, SETTING, AND PARTICIPANTS

This study is a retrospective subanalysis of HARBOR (a phase 3, double-masked, multicenter, randomized, active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg ranibizumab administered monthly or on an as-needed basis (PRN) in patients with subfoveal neovascular age-related macular degeneration). A total of 1097 patients with neovascular age-related macular degeneration were randomized to intravitreal ranibizumab, 0.5 or 2.0 mg, administered monthly or as needed (PRN) with monthly monitoring. Of the 1097 patients, 1057 were included in the analysis for early responders (best-corrected visual acuity [BCVA] obtained at baseline and month 3), and 988 patients were included in the analysis for delayed responders (BCVA obtained at baseline, month 3, and month 12). The HARBOR study began July 7, 2009, with the primary 12-month end point completed on August 5, 2011, ongoing to 24 months. Data analysis for the subgroup was performed from January 4, 2013, through December 17, 2015.

INTERVENTIONS

Patients were categorized based on BCVA outcomes as early 15-letter responders (gained ≥15 letters from baseline at month 3) or delayed 15-letter responders (did not gain ≥15 letters from baseline at month 3 but did so at month 12).

MAIN OUTCOMES AND MEASURES

Changes from baseline in BCVA and central foveal thickness (CFT).

RESULTS

In total, 266 early and 135 delayed 15-letter responders were identified. In the 0.5-mg monthly, 0.5-mg PRN, 2.0-mg monthly, and 2.0-mg PRN treatment groups, 63 (24.0%) of 263, 65 (24.6%) of 264, 68 (25.7%) of 265, and 70 (26.4%) of 265 patients were early responders, respectively, and 40 (16.3%) of 246, 31 (12.6%) of 247, 35 (14.1%) of 248, and 29 (11.7%) of 247 patients were delayed responders, respectively. By month 12, early vs delayed responders in the PRN treatment groups received 7.5 vs 7.4 ranibizumab injections, respectively (P = .84). More than 80% of early responders receiving PRN treatment maintained 15-letter or greater gains at month 24. At baseline, early vs delayed responders had worse BCVA (49.8 vs 55.4 letters; P < .001) and greater CFT (374.9 vs 339.0 µm; P = .02), although anatomical results were comparable by month 3 (CFT, 187.7 vs 188.9 µm).

CONCLUSIONS AND RELEVANCE

Improvement of 15 letters or more from baseline occurred in 266 (25.2%) of 1057 patients within 3 months of beginning ranibizumab treatment, whereas an additional 135 (13.7%) of 988 patients achieved this gain by 12 months. The 2 cohorts had similar anatomical temporal response patterns. PRN treatment with monthly monitoring was effective in maintaining early vision gains and allowing delayed vision gains. These results suggest that vision improvement can continue in some patients after macular edema resolves and CFT decreases stabilize.

Authors+Show Affiliations

Ophthalmic Consultants of Long Island, Lynbrook, New York.The Retina Center at Pali Momi, Aiea, Hawaii3Retina Consultants of Hawaii, University of Hawaii School of Medicine, Honolulu.Retina Northwest, Portland, Oregon.Genentech Inc, South San Francisco, California.Genentech Inc, South San Francisco, California.

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

27010625

Citation

Stoller, Glenn L., et al. "Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration." JAMA Ophthalmology, vol. 134, no. 5, 2016, pp. 545-553.
Stoller GL, Kokame GT, Dreyer RF, et al. Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2016;134(5):545-553.
Stoller, G. L., Kokame, G. T., Dreyer, R. F., Shapiro, H., & Tuomi, L. L. (2016). Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration. JAMA Ophthalmology, 134(5), pp. 545-553. doi:10.1001/jamaophthalmol.2016.0379.
Stoller GL, et al. Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration. JAMA Ophthalmol. 2016 May 12;134(5):545-553. PubMed PMID: 27010625.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Patterns of Early and Delayed Visual Response to Ranibizumab Treatment for Neovascular Age-Related Macular Degeneration. AU - Stoller,Glenn L, AU - Kokame,Gregg T, AU - Dreyer,Richard F, AU - Shapiro,Howard, AU - Tuomi,Lisa L, PY - 2016/3/25/entrez PY - 2016/3/25/pubmed PY - 2017/5/4/medline SP - 545 EP - 553 JF - JAMA ophthalmology JO - JAMA Ophthalmol VL - 134 IS - 5 N2 - IMPORTANCE: Understanding the range of temporal responses to ranibizumab is critical for the assessment of individualized treatment regimens for neovascular age-related macular degeneration. OBJECTIVE: To examine patterns of visual and anatomical response to ranibizumab treatment. DESIGN, SETTING, AND PARTICIPANTS: This study is a retrospective subanalysis of HARBOR (a phase 3, double-masked, multicenter, randomized, active treatment-controlled study of the efficacy and safety of 0.5 mg and 2.0 mg ranibizumab administered monthly or on an as-needed basis (PRN) in patients with subfoveal neovascular age-related macular degeneration). A total of 1097 patients with neovascular age-related macular degeneration were randomized to intravitreal ranibizumab, 0.5 or 2.0 mg, administered monthly or as needed (PRN) with monthly monitoring. Of the 1097 patients, 1057 were included in the analysis for early responders (best-corrected visual acuity [BCVA] obtained at baseline and month 3), and 988 patients were included in the analysis for delayed responders (BCVA obtained at baseline, month 3, and month 12). The HARBOR study began July 7, 2009, with the primary 12-month end point completed on August 5, 2011, ongoing to 24 months. Data analysis for the subgroup was performed from January 4, 2013, through December 17, 2015. INTERVENTIONS: Patients were categorized based on BCVA outcomes as early 15-letter responders (gained ≥15 letters from baseline at month 3) or delayed 15-letter responders (did not gain ≥15 letters from baseline at month 3 but did so at month 12). MAIN OUTCOMES AND MEASURES: Changes from baseline in BCVA and central foveal thickness (CFT). RESULTS: In total, 266 early and 135 delayed 15-letter responders were identified. In the 0.5-mg monthly, 0.5-mg PRN, 2.0-mg monthly, and 2.0-mg PRN treatment groups, 63 (24.0%) of 263, 65 (24.6%) of 264, 68 (25.7%) of 265, and 70 (26.4%) of 265 patients were early responders, respectively, and 40 (16.3%) of 246, 31 (12.6%) of 247, 35 (14.1%) of 248, and 29 (11.7%) of 247 patients were delayed responders, respectively. By month 12, early vs delayed responders in the PRN treatment groups received 7.5 vs 7.4 ranibizumab injections, respectively (P = .84). More than 80% of early responders receiving PRN treatment maintained 15-letter or greater gains at month 24. At baseline, early vs delayed responders had worse BCVA (49.8 vs 55.4 letters; P < .001) and greater CFT (374.9 vs 339.0 µm; P = .02), although anatomical results were comparable by month 3 (CFT, 187.7 vs 188.9 µm). CONCLUSIONS AND RELEVANCE: Improvement of 15 letters or more from baseline occurred in 266 (25.2%) of 1057 patients within 3 months of beginning ranibizumab treatment, whereas an additional 135 (13.7%) of 988 patients achieved this gain by 12 months. The 2 cohorts had similar anatomical temporal response patterns. PRN treatment with monthly monitoring was effective in maintaining early vision gains and allowing delayed vision gains. These results suggest that vision improvement can continue in some patients after macular edema resolves and CFT decreases stabilize. SN - 2168-6173 UR - https://www.unboundmedicine.com/medline/citation/27010625/Patterns_of_Early_and_Delayed_Visual_Response_to_Ranibizumab_Treatment_for_Neovascular_Age_Related_Macular_Degeneration_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/jamaophthalmol.2016.0379 DB - PRIME DP - Unbound Medicine ER -