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Good early results seen with anti-VEGF refillable port delivery system
Improvements in BCVA were comparable with monthly injection treatments for AMD.
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CHICAGO — First-in-human results on the efficacy of a refillable port delivery system filled with ranibizumab for the treatment of age-related macular degeneration are comparable to those reported for once-monthly intravitreal injections of 0.5-mg ranibizumab, a speaker said here.
Even if patients do not receive treatment each month, they still must adhere to a strict once-monthly monitoring regimen, Anat Loewenstein, MD, said at Retina Subspecialty Day preceding the joint meeting of the American Academy of Ophthalmology and Asia-Pacific Academy of Ophthalmology.
“The best outcomes are associated with monthly treatment and/or office visits,” she said. “Over time, this represents a treatment burden for the patient, caregiver and physician.”
Citing the LUMIERE Study, she said patients receive an average of 5.1 intravitreal injections per year, with an average of 8.6 office visits per year.
Study data
To eliminate patient burden, Loewenstein and colleagues examined a refillable non-biodegradable Lucentis (ranibizumab, Genentech) port delivery system (PDS, Genentech) that is specifically customized for standard ranibizumab delivery (10 mg/mL) over an extended period of time.
A phase 1 uncontrolled trial, completed in Latvia, tested the efficacy and safety of the PDS and included 20 treatment-naïve AMD patients who were evaluated on a monthly basis.
Anat Loewenstein
Study participants also had choroidal neovascularization secondary to AMD, retinal thickness due to edema of at least 300 µm in the study eye, best corrected visual acuity of 20/40 or less in the study eye, and BCVA of 20/40 or more in the fellow eye.
Each PDS was initially filled with 250 µg of ranibizumab. The PDS was surgically implanted in the pars plana below the conjunctiva, with no scleral sutures needed.
Seventy-seven mild and moderate study-related adverse events were observed; four significant adverse events, including one case of endophthalmitis, two vitreous hemorrhages and one traumatic cataract, were associated with the implantation procedure.
The device was maintained in the eye for the 12-month duration of the trial, Loewenstein said. The PDS could be seen inside the eye only after pupillary dilation.
Treatment with the PDS resulted in an improvement in BCVA that was comparable to treatment with monthly injections. A sustained reduction in macular thickness and choroidal neovascularization leakage was also observed.
Study details
The primary objective of the study was to demonstrate safety, specifically regarding the incidence and severity of adverse events in relation to complications resulting from implantation, refilling and explantation of the PDS, Loewenstein said.
Secondary objectives of the study included an improvement in BCVA, a reduction in macular thickness and a reduction in leakage in the choroidal neovascularization area.
PDS implants were refilled, if necessary, according to predetermined criteria. The total refill dose injected into the PDS was 500 µg of ranibizumab; 250 µg of ranibizumab acted as an intravitreal bolus, and 250 µg of ranibizumab was released in a sustained manner over time.
Final study data on the PDS are expected in May 2014. –by Ashley Biro