Skip to main content
Journal cover image

RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.

Publication ,  Journal Article
Wolf, S; Balciuniene, VJ; Laganovska, G; Menchini, U; Ohno-Matsui, K; Sharma, T; Wong, TY; Silva, R; Pilz, S; Gekkieva, M; RADIANCE Study Group,
Published in: Ophthalmology
March 2014

OBJECTIVE: To compare the efficacy and safety of ranibizumab 0.5 mg, guided by visual acuity (VA) stabilization or disease activity criteria, versus verteporfin photodynamic therapy (vPDT) in patients with visual impairment due to myopic choroidal neovascularization (CNV). DESIGN: Phase III, 12-month, randomized, double-masked, multicenter, active-controlled study. PARTICIPANTS: Patients (N = 277) with visual impairment due to myopic CNV. METHODS: Patients were randomized to receive ranibizumab on day 1, month 1, and thereafter as needed guided by VA stabilization criteria (group I, n = 106); ranibizumab on day 1 and thereafter as needed guided by disease activity criteria (group II, n=116); or vPDT on day 1 and disease activity treated with ranibizumab or vPDT at investigators' discretion from month 3 (group III, n = 55). MAIN OUTCOME MEASURES: Mean average best-corrected visual acuity (BCVA) change from baseline to month 1 through months 3 (primary) and 6, mean BCVA change and safety over 12 months. RESULTS: Ranibizumab treatment in groups I and II was superior to vPDT based on mean average BCVA change from baseline to month 1 through month 3 (group I: +10.5, group II: +10.6 vs. group III: +2.2 Early Treatment Diabetic Retinopathy Study [ETDRS] letters; both P<0.0001). Ranibizumab treatment guided by disease activity was noninferior to VA stabilization-guided retreatment based on mean average BCVA change from baseline to month 1 through month 6 (group II: +11.7 vs. group I: +11.9 ETDRS letters; P<0.00001). Mean BCVA change from baseline to month 12 was +13.8 (group I), +14.4 (group II), and +9.3 ETDRS letters (group III). At month 12, 63.8% to 65.7% of patients showed resolution of myopic CNV leakage. Patients received a median of 4.0 (group I) and 2.0 (groups II and III) ranibizumab injections over 12 months. No deaths or cases of endophthalmitis and myocardial infarction occurred. CONCLUSIONS: Ranibizumab treatment, irrespective of retreatment criteria, provided superior BCVA gains versus vPDT up to month 3. Ranibizumab treatment guided by disease activity criteria was noninferior to VA stabilization criteria up to month 6. Over 12 months, individualized ranibizumab treatment was effective in improving and sustaining BCVA and was generally well tolerated in patients with myopic CNV.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

March 2014

Volume

121

Issue

3

Start / End Page

682 / 92.e2

Location

United States

Related Subject Headings

  • Visual Acuity
  • Verteporfin
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retreatment
  • Ranibizumab
  • Porphyrins
  • Photosensitizing Agents
  • Photochemotherapy
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Wolf, S., Balciuniene, V. J., Laganovska, G., Menchini, U., Ohno-Matsui, K., Sharma, T., … RADIANCE Study Group, . (2014). RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology, 121(3), 682-92.e2. https://doi.org/10.1016/j.ophtha.2013.10.023
Wolf, Sebastian, Vilma Jurate Balciuniene, Guna Laganovska, Ugo Menchini, Kyoko Ohno-Matsui, Tarun Sharma, Tien Y. Wong, et al. “RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.Ophthalmology 121, no. 3 (March 2014): 682-92.e2. https://doi.org/10.1016/j.ophtha.2013.10.023.
Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, et al. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682-92.e2.
Wolf, Sebastian, et al. “RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia.Ophthalmology, vol. 121, no. 3, Mar. 2014, pp. 682-92.e2. Pubmed, doi:10.1016/j.ophtha.2013.10.023.
Wolf S, Balciuniene VJ, Laganovska G, Menchini U, Ohno-Matsui K, Sharma T, Wong TY, Silva R, Pilz S, Gekkieva M, RADIANCE Study Group. RADIANCE: a randomized controlled study of ranibizumab in patients with choroidal neovascularization secondary to pathologic myopia. Ophthalmology. 2014 Mar;121(3):682–92.e2.
Journal cover image

Published In

Ophthalmology

DOI

EISSN

1549-4713

Publication Date

March 2014

Volume

121

Issue

3

Start / End Page

682 / 92.e2

Location

United States

Related Subject Headings

  • Visual Acuity
  • Verteporfin
  • Vascular Endothelial Growth Factor A
  • Treatment Outcome
  • Tomography, Optical Coherence
  • Retreatment
  • Ranibizumab
  • Porphyrins
  • Photosensitizing Agents
  • Photochemotherapy