Efficacy and Safety of Two Treatment Regimens of 0.5 mg Ranibizumab Intravitreal Injections Guided by Functional and/or Anatomical Criteria, in Patients With Neovascular Age-related Macular Degeneration

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01780935
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injections of 0.5 mg Ranibizumab

Study Details

This study will evaluate and compare two individualized ranibizumab treatment regimens in patients with neovascular (wet) AMD aiming to achieve and to maintain a maximum visual function benefit, while aiming to avoid unnecessary intravitreal injections. The results will be used to generate further recommendations on functional and anatomical monitoring of the disease and timing of treatment administration for patients with neovascular AMD. In this context, the study will investigate the utility of optical coherence tomography (OCT) to aid retreatment decisions with ranibizumab.

Key Dates

First listed
Jan 31, 2013
Start date
Jun 3, 2013
Status verified
Jul 2017
Primary completion
Jul 9, 2015
Completion
Jul 9, 2015

Study Design

Enrollment
671 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: RBZ 0.5 mg: VA only (Group I)
    RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
  • Experimental: RBZ 0.5 mg: VA and/or OCT (Group II)
    RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).

Primary Outcome Measure

Average Best-corrected Visual Acuity (BCVA) (Letters) Change up to Month 12 [ Time Frame: up to Month 12 ]

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