Clinical trial NCT03071055: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF
Official title: Efficacy of Biweekly Ranibizumab (0.5 mg) for Exudative Macular Degeneration Retinal Edema Refractory to Anti-VEGF Therapy Comparing Syringe Preparation Time Using Ranibizumab Vial and Pre-filled Syringe
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exudative Age Related Macular Degeneration
Keywords: Macular Degeneration
AMD
Wet AMD
Lucentis
Lead sponsor: Southeast Clinical Research Associates, LLC
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2017-03-06
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 24 week open label study to assess the efficacy of bi-weekly ranibizumab for patients with retinal fluid due to exudative macular degeneration refractory to monthly therapy.

Detailed description: This is a 24 week, open-label, non-randomized, phase II study evaluating intravitreal ranibizumab dosed every 14 days in subjects with exudative macular degeneration who have persistent intraretinal or subretinal fluid despite chronic monthly anti-VEGF therapy (\>6 months). Subjects must have had a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the 6 months preceding enrollment.

Consented, enrolled subjects will receive multiple open-label intravitreal injections of 0.5 mg ranibizumab administered every 14 days (± 3 days). Subjects who have resolution of fluid will convert to monthly ranibizumab for the remainder of the study. If fluid recurs, subjects will return to biweekly treatment.

Patients will be assigned to receive treatment with either ranibizumab vial or PFSs so that approximately 10 patients will be treated with each delivery method option, and syringe preparation time (SPT) will be measured by an assistant who will be observing the procedure and timing with an automated stopwatch.

Eligibility criteria: Inclusion Criteria:

* Age \> 50 years
* Exudative age related macular degeneration in study eye involving the fovea
* Best Corrected Visual Acuity (by ETDRS) letter score in study eye of \< 85 and \> 24 (approximate Snellen equivalent 20/20 to 20/320)
* Persistent intraretinal or subretinal fluid on SD OCT despite a minimum of 5 intravitreal anti-VEGF injections administered every 4-6 weeks in the in the 6 months preceding enrollment in the study eye
* At least 30 days from last intravitreal anti-VEGF injection in the study eye

Exclusion Criteria:

* Patient who are receiving systemic anti-VEGF or proangiogenic therapy
* Patients on chronic high doses corticosteroid therapy (\> than 10 mg of oral prednisone or equivalent greater than 10 days)
* Patients on chronic immunosuppressant therapy
* Patients on drugs known to have toxic side effects on the retina e.g. hydroxychloroquine
* History of intravitreal corticosteroids in study eye within 4 months of baseline
* Uncontrolled hypertension (defined as systolic \>180 mm Hg and/or diastolic \> 100 mm Hg while patient is sitting)
* History of stroke or APTC event in the previous year
* Any intraocular surgery in study eye within 90 days of baseline
* Presence of vitreomacular traction in study eye
* Presence of significant epiretinal proliferation in study eye
* Evidence of active infection in either eye
* Uncontrolled glaucoma in the study eye defined as a pressure \> 25 mmHg on maximal medical therapy

Primary outcomes:
measure: The primary outcome measure is mean change in ETDRS BCVA visual acuity
timeFrame: 24 weeks
Secondary outcomes:
measure: Proportion of eyes that gain or lose >0 letters at 24 weeks
timeFrame: 24 weeks
measure: Proportion of eyes that gain or lose > 5 letters at 24 weeks
timeFrame: 24 weeks
measure: Proportion of eyes that gain or lose > 10 letters at 24 weeks
timeFrame: 24 weeks
measure: Proportion of eyes that gain or lose > 15 letters at 24 weeks
timeFrame: 24 weeks
measure: To compare syringe preparation time (SPT) using ranibizumab vial and pre-filled syringe (PFS) in a real world clinical setting
timeFrame: 24 weeks
measure: • Proportion of eyes with complete resolution of subretinal fluid and/or intraretinal fluid on SD OCT (macular cube) at 24 weeks
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PA
state: North Carolina
city: Statesville
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PA
state: North Carolina
Study officials:
References: