Study to Investigate the Safety and Efficacy of Ranibizumab in Patients With Choroidal Neovascularisation Due to Causes Other Than Age Related Macular Degeneration

Sponsor
University of Melbourne
Study ID
NCT01628354
Phase
PHASE4
Status
Completed

Conditions

  • Choroidal Neovascularization
  • Retinal Pigment Epithelial Detachment

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    All patients will receive an intravitreal injection of ranibizumab 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with ranibizumab 0.5 mg based on measurements of visual acuity, Optical coherene tomography (OCT) findings and clinical appearance. A drop of vision of \>5 letters or increase in retinal thickness of \>100 um on OCT will trigger re-treatment as long as 14 days has elapsed since last treatment.

Study Details

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to causes other than age related macular degeneration (AMD) and pigment epithelial detachments (blisters of fluid under the retina) secondary to AMD with ranibizumab (Lucentis). These groups of patients have to date been excluded from the multicentre trials demonstrating significant benefit of Ranibizumab in the treatment of AMD.

Key Dates

First listed
Jun 26, 2012
Start date
Feb 29, 2008
Status verified
Jun 2012
Primary completion
Apr 30, 2010
Completion
Apr 30, 2010

Study Design

Enrollment
49 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Mean change from baseline in best corrected visual acuity [ Time Frame: 12 months ]

Related Studies