September 2016
Volume 57, Issue 12
Open Access
ARVO Annual Meeting Abstract  |   September 2016
Efficacy and safety of ranibizumab 0.5 mg (RBZ) in patients with visual impairment due to choroidal neovascularization (CNV) associated with rare diseases: 6-month results from MINERVA
Author Affiliations & Notes
  • Timothy Y Y Lai
    Ophthalmology & Visual Sciences, Chinese University of Hong Kong, Kowloon, Hong Kong
  • Sabine Desset-Brethes
    Ophthalmology, Novartis Pharma AG, Basel, Switzerland
  • Vladimir Bezlyak
    Ophthalmology, Novartis Pharma AG, Basel, Switzerland
  • Melissa Liew
    Ophthalmology, Novartis Pharma AG, Basel, Switzerland
  • Footnotes
    Commercial Relationships   Timothy Lai, Alcon, Inc. (C), Allergan, Inc. (C), Bayer Healthcare (F), Bayer Healthcare (C), Novartis Pharmaceuticals (F), Novartis Pharmaceuticals (C), Novartis Pharmaceuticals (R); Sabine Desset-Brethes, Novartis Pharma AG, Basel, Switzerland (E); Vladimir Bezlyak, Novartis Pharma, AG, Basel, Switzerland (E); Melissa Liew, Novartis Pharma AG, Basel, Switzerland (E)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science September 2016, Vol.57, No Pagination Specified. doi:
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      Timothy Y Y Lai, Sabine Desset-Brethes, Vladimir Bezlyak, Melissa Liew; Efficacy and safety of ranibizumab 0.5 mg (RBZ) in patients with visual impairment due to choroidal neovascularization (CNV) associated with rare diseases: 6-month results from MINERVA. Invest. Ophthalmol. Vis. Sci. 201657(12):.

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      © 2017 Association for Research in Vision and Ophthalmology.

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Abstract

Purpose : To evaluate the efficacy and safety of RBZ in patients with visual impairment due to CNV other than neovascular age-related macular degeneration and myopic CNV. The 6-month (M) results are reported here.

Methods : MINERVA is a 12M, phase III, randomized, double-masked, sham-controlled, multicenter study including adult (≥18 years) and adolescent (≥12–<18 years) patients. Adult patients (N=178) were randomized (2:1) to receive RBZ (n=119) or sham (n=59) at baseline (BSL) and then treated as needed. From M2, adult patients in both groups could receive open-label RBZ as needed. The primary endpoint was change in best-corrected visual acuity (BCVA) from BSL to M2. Secondary outcomes included changes from BSL in BCVA to M1/M2 and central subfield thickness (CSFT) to M2, absence of intra-/sub-retinal fluid at M2, ≥10/≥15 letter gainers at M2, treatment exposure, and safety up to M6. Secondary efficacy endpoints are presented for patients initially assigned to RBZ and sham. Moreover, a subgroup analysis was conducted on the primary endpoint based on 5 pre-defined CNV etiology subgroups.

Results : Data have been analyzed for adults up to M6 and presented here. Of the 178 randomized patients, 174 (97.8%) completed M6. The baseline characteristics were well balanced across the 2 arms. The primary endpoint was met with RBZ showing superior efficacy vs sham from BSL to M2 (adjusted least-squares [LS] mean BCVA: +9.5 letters vs −0.4 letters; one-sided p<0.001). Across the 5 CNV etiology subgroups, the treatment effect (adjusted LS means) ranged from 5.02–14.57 letters (Fig. 1). At M6, change in BCVA (Fig. 2) was +10.3 letters (RBZ) vs +7.5 letters (sham). Adjusted LS mean change in CSFT from BSL to M2 was −77.0 µm (RBZ) vs +9.8 µm (sham); one-sided p<0.001. At M2, intra-/sub-retinal fluid resolved in 67.4%/56.0% (RBZ) vs 29.2%/14.0% (sham) of patients. The proportion of patients with ≥10/≥15 letter gain at M2 was 42.4%/31.4% (RBZ) vs 14.0%/12.3% (sham). Out of a possible 6 (RBZ) and 4 (sham) RBZ injections, patients received a mean of 3.7 (RBZ) vs 2.7 (sham) RBZ injections. No new safety findings were reported up to M6.

Conclusions : Ranibizumab showed significant gain of ~10 letters at M2 that was maintained at M6. RBZ is effective for the treatment of CNV regardless of the underlying etiology with no new safety concerns.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.

 

 

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