Wet AMD Recurrence Rate in Patients Stable on Three Month Ranibizumab Dosing

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The current norm in clinical practice for the treatment of choroidal neovascular membranes (CNVM) secondary to Age-related Macular Degeneration(AMD) involves monthly injections of Ranibizumab until the disease is stabilized. At this point, most physicians tend to follow one of two treatment regimens. 'Treat -and-observe' entails regular follow-up of stable patients, with treatment thereafter only in the presence of disease recurrence. Alternatively, in a 'treat-and-extend' dosing strategy, intervals between treatments are extended as long as disease remains stable. Many clinicians, who employ a treat-and-extend dosing regimen, do not extend their treatment intervals beyond 3 months. However, it is possible that the subgroup of patients on every three months 'treat-and-extend' dosing may represent a uniquely, stable population that would perform particularly well on an observational regimen with regular follow-up. We hypothesize that there will be a low CNVM recurrence rate in wet AMD patients stable on every three months Ranibizumab dosing ('treat-and-extend'), who begin a treat-and-observe protocol.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Treatments: Ranibizumab

Criteria

Inclusion Criteria:

• Age 50 years or more

• Active primary or recurrent choroidal neovascularization secondary to AMD in the study eye, currently stable on an 'every three month' treatment regimen (established using a treat and extend dosing protocol)

• Best-corrected visual acuity of Counting Fingers or better (Snellen equivalent) in the study eye

• All IVFA lesion types and lesion sizes

• One eye per subject (the "study eye"). If both eyes are eligible, the one with better VA will be selected unless, for medical reasons, the other is more appropriate

Exclusion Criteria:

• Treatment of the current choroidal neovascular membrane with verteporfin photodynamic therapy (PDT), external-beam radiation therapy, transpupillary thermotherapy, or subfoveal laser photocoagulation (or juxtafoveal or extrafoveal laser photocoagulation

• History of vitrectomy surgery in the study eye

• Individuals with choroidal neovascularization from causes other than AMD