NCT01025232

A Study of Intravitreal Injections of 2.0mg Ranibizumab in Subjects With Chronic Fluid On OCT Post Multiple Injections With Ranibizumab (Super-dose Anti-VEgf SAVE Trial)

A Phase I/II Open Label, Multicenter Study of the Safety, Tolerability and Efficacy of Multiple Intravitreal Injections of (Super-dose Anti-VEgf SAVE Trial) 2.0mg Ranibizumab in Subjects With Chronic Fluid on OCT Post Multiple Injections With Ranibizumab

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: David M. Brown, M.D. · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine whether 2.0mg Ranibizumab is effective in the treatment of recurrent fluid.

Detailed description

This is an open-label, Phase I/II study of intravitreally administered 2.0 mg ranibizumab in subjects with persistent fluid or recurrent fluid on OCT after having received at least nine ranibizumab injections in the past twelve months. Consented, enrolled subjects will receive have monthly ETDRS BCVA, ophthalmic examination and OCTs evaluation using Stratus, Cirrus and Spectralis machines. Fluorescein angiography and autofluorescence will be done at BSL, and Months 6 and 12. DNA samples for genetic analysis will be collected at baseline. Subjects will receive open-label intravitreal injections of 2.0 mg ranibizumab administered every 28 days for 3 months: Following the three loading doses, all patients will receive a minimum "capped" PRN treatment (all patients will receive 2.0 mg intravitreal ranibizumab quarterly). Dosing should not occur earlier than 22 days after the previous treatment. Study visits should be scheduled to occur every 30 (±7) days relative to the date of the first injection (Day 0). Subjects will be randomized into two re-treatment cohorts for additional re-treatment, if needed: * Cohort A - Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. * Cohort B - Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal ,or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab.

Conditions

• Age Related Macular Degeneration
• Choroidal Neovascular Membrane
• Subfoveal Neovascular Age-Related Macular Degeneration
• Macular Degeneration
• Wet Age-Related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Ranibizumab	Intravitreal Injection of 2.0mg formulation

Timeline

• Start date: 2009-12-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-12-03
• Last updated: 2017-01-02
• Results posted: 2017-01-02

Locations

2 sites across 1 country: United States