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

NCT01453920 | Completed Phase 4 DMC

• 1 other identifier: 11-0686-AE
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Age Related Macular Degeneration

Keywords

Age Related Macular Degeneration; Choroidal Neovascular Membrane

Outcome Measures

Primary Outcomes (1)

• Prevalence of CNVM recurrence

  To determine the prevalence of CNVM recurrence in each study group as defined by visual acuity (VA), dilated fundus exmaination (DFEx), Spectral Domain Optical Coherence Tomography (SDOCT) +/- Intravenous Flourescein Angiography (IVFA).

  6 months

Secondary Outcomes (7)

• Mean change in VA between baseline

  6 months

• Proportion of patients losing > 15 letters (3 lines) from baseline

  6 months

• Number of Ranibizumab injections

  6 months

• Presence of subretinal and/or intraretinal fluid on SDOCT

  6 months

• Central Retinal Thickness measurement on SDOCT

  6 months

Study Arms (2)

Treat-and-extend

ACTIVE COMPARATOR

Ranibizumab injection every 3 months, with follow-up assessments at each visit (every 3 months)

Drug: Ranibizumab

Treat-and-observe'

EXPERIMENTAL

No injection, follow-up assessments every month

Drug: Ranibizumab

Interventions

Ranibizumab DRUG

Intravitreal Ranibizumab 0.05cc (10mg/ml)

Also known as: Lucentis

Treat-and-extend

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Michael H Brent, MD FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: August 28, 2012

Record last verified: 2012-08

Locations

CA (1)