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Pilot study to evaluate the role of high-dose ranibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with persistent/recurrent macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study).
Eye (Lond) 2012; 26(9):1181-7E

Abstract

PURPOSE

To determine the efficacy of intravitreal ranibizumab 2.0 mg in patients with recalcitrant neovascular age-related macular degeneration (AMD).

METHODS

This single-masked, randomized, prospective, pilot study enrolled patients with subfoveal neovascular AMD. All study eyes had persistent subretinal (SRF) or intraretinal fluid (IRF) on spectral-domain optical coherence tomography (SD-OCT) <30 days following at least 6 monthly intravitreal injections of ranibizumab or bevacizumab. Patients were randomized 2 : 1 to receive either ranibizumab 2.0 or 0.5 mg. Following three-loading treatments 4-weeks apart, both groups were treated using a 'treat and extend' regimen guided by eye-tracked SD-OCT through month 12. The primary end point was the mean change in best-corrected visual acuity (BCVA) at month 6.

RESULTS

Nine eyes of 9 patients (mean age ± SD, 82.0 ± 5.8 years) were enrolled. Seven eyes received ranibizumab 2.0 mg and two eyes received 0.5 mg. Owing to the small number of patients enrolled, no statistical comparison could be made between the two dosages. At month 6, the mean improvement in BCVA was +6.1 ± 3.7 (W=0, P<0.001) ETDRS letters and +2.0 ETDRS letters in the 2.0 and 0.5 mg groups, respectively. In the 2.0 mg group, there was a statistically significant decline in central foveal thickness, SRF and maximum pigment epithelial detachment height at 6 months compared with baseline. No adverse events were reported in either group.

CONCLUSION

Ranibizumab 2.0 mg has the potential to maintain or improve BCVA in some patients with persistent or recurrent SRF or IRF secondary to neovascular AMD despite prior monthly intravitreal anti-vascular endothelial growth factor therapy with the standard dose.

Authors+Show Affiliations

Vitreous-Retina-Macula Consultants of New York and LuEsther T. Mertz Retinal Research Center, Manhattan Eye, Ear and Throat Hospital, New York, NY 10022, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

22878451

Citation

Fung, A T., et al. "Pilot Study to Evaluate the Role of High-dose Ranibizumab 2.0 Mg in the Management of Neovascular Age-related Macular Degeneration in Patients With Persistent/recurrent Macular Fluid <30 Days Following Treatment With Intravitreal anti-VEGF Therapy (the LAST Study)." Eye (London, England), vol. 26, no. 9, 2012, pp. 1181-7.
Fung AT, Kumar N, Vance SK, et al. Pilot study to evaluate the role of high-dose ranibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with persistent/recurrent macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study). Eye (Lond). 2012;26(9):1181-7.
Fung, A. T., Kumar, N., Vance, S. K., Slakter, J. S., Klancnik, J. M., Spaide, R. S., & Freund, K. B. (2012). Pilot study to evaluate the role of high-dose ranibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with persistent/recurrent macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study). Eye (London, England), 26(9), pp. 1181-7. doi:10.1038/eye.2012.174.
Fung AT, et al. Pilot Study to Evaluate the Role of High-dose Ranibizumab 2.0 Mg in the Management of Neovascular Age-related Macular Degeneration in Patients With Persistent/recurrent Macular Fluid <30 Days Following Treatment With Intravitreal anti-VEGF Therapy (the LAST Study). Eye (Lond). 2012;26(9):1181-7. PubMed PMID: 22878451.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Pilot study to evaluate the role of high-dose ranibizumab 2.0 mg in the management of neovascular age-related macular degeneration in patients with persistent/recurrent macular fluid <30 days following treatment with intravitreal anti-VEGF therapy (the LAST Study). AU - Fung,A T, AU - Kumar,N, AU - Vance,S K, AU - Slakter,J S, AU - Klancnik,J M, AU - Spaide,R S, AU - Freund,K B, Y1 - 2012/08/10/ PY - 2012/8/11/entrez PY - 2012/8/11/pubmed PY - 2013/1/18/medline SP - 1181 EP - 7 JF - Eye (London, England) JO - Eye (Lond) VL - 26 IS - 9 N2 - PURPOSE: To determine the efficacy of intravitreal ranibizumab 2.0 mg in patients with recalcitrant neovascular age-related macular degeneration (AMD). METHODS: This single-masked, randomized, prospective, pilot study enrolled patients with subfoveal neovascular AMD. All study eyes had persistent subretinal (SRF) or intraretinal fluid (IRF) on spectral-domain optical coherence tomography (SD-OCT) <30 days following at least 6 monthly intravitreal injections of ranibizumab or bevacizumab. Patients were randomized 2 : 1 to receive either ranibizumab 2.0 or 0.5 mg. Following three-loading treatments 4-weeks apart, both groups were treated using a 'treat and extend' regimen guided by eye-tracked SD-OCT through month 12. The primary end point was the mean change in best-corrected visual acuity (BCVA) at month 6. RESULTS: Nine eyes of 9 patients (mean age ± SD, 82.0 ± 5.8 years) were enrolled. Seven eyes received ranibizumab 2.0 mg and two eyes received 0.5 mg. Owing to the small number of patients enrolled, no statistical comparison could be made between the two dosages. At month 6, the mean improvement in BCVA was +6.1 ± 3.7 (W=0, P<0.001) ETDRS letters and +2.0 ETDRS letters in the 2.0 and 0.5 mg groups, respectively. In the 2.0 mg group, there was a statistically significant decline in central foveal thickness, SRF and maximum pigment epithelial detachment height at 6 months compared with baseline. No adverse events were reported in either group. CONCLUSION: Ranibizumab 2.0 mg has the potential to maintain or improve BCVA in some patients with persistent or recurrent SRF or IRF secondary to neovascular AMD despite prior monthly intravitreal anti-vascular endothelial growth factor therapy with the standard dose. SN - 1476-5454 UR - https://www.unboundmedicine.com/medline/citation/22878451/Pilot_study_to_evaluate_the_role_of_high_dose_ranibizumab_2_0_mg_in_the_management_of_neovascular_age_related_macular_degeneration_in_patients_with_persistent/recurrent_macular_fluid_<30_days_following_treatment_with_intravitreal_anti_VEGF_therapy__the_LAST_Study__ L2 - http://dx.doi.org/10.1038/eye.2012.174 DB - PRIME DP - Unbound Medicine ER -