AI Article Synopsis
- - The study aimed to compare the types and rates of complications from the Port Delivery System (PDS) with other ocular implants that cross the sclera, focusing on long-term safety from clinical trials and real-world data.
- - A systematic literature review found reports from 16 clinical trials and 43 real-world studies, which detailed 30 complications associated with various ocular implants, highlighting a generally acceptable safety profile.
- - The rates of specific complications for the PDS were consistent with those of other ocular devices, suggesting similar long-term safety across these implant systems in ophthalmology.
Article Abstract
Objectives: To determine whether the types and rates of post-surgical complications associated with the Port Delivery System with ranibizumab (PDS) are comparable with those reported for other ocular implants that cross the sclera.
Methods: Systematic literature reviews were conducted to determine the long-term (≥ 18-month) safety of ocular implants that cross the sclera in clinical trials and real-world studies. Complication types and rates were compared with those reported for the PDS in phase III clinical trials (Archway, Pagoda, and Pavilion).
Results: Sixteen clinical trials (24 publications) and 43 real-world studies were identified reporting 30 complications in eyes with 15 implant types and 8 ocular diseases. Implants were associated with an acceptable, well-characterized safety profile, with most complications resolving spontaneously or with treatment. Device-related complications were reported in 0.7% (0.0-5.0%) of study eyes in clinical trials and 1.3% (0.0-14.5%) of eyes in real-world studies. Rates of conjunctival complications were 2.1% (0.0-22.8%) and 2.2% (0.9-4.6%), respectively. The overall types and rates of adverse events of special interest reported for the PDS in phase III trials (cataract, conjunctival bleb, vitreous hemorrhage, conjunctival erosion, conjunctival retraction, endophthalmitis, implant dislocation, retinal detachment, and hyphema) were within the ranges reported for other ocular implants.
Conclusions: The rates of complications reported in phase III clinical trials for the PDS were within the ranges reported for other ocular implants that cross the sclera. This suggests that the long-term safety of the PDS is consistent with other ocular devices established in ophthalmology clinical practice.
Trial Registration: PROSPERO international prospective register of systematic reviews: CRD5202234129, CRD42022343129.
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|---|---|
| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11341515 | PMC |
| http://dx.doi.org/10.1007/s40123-024-01001-1 | DOI Listing |
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