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Systematic Literature Reviews Comparing the Long-Term Safety Outcomes for the Port Delivery System with Ranibizumab (PDS) Versus Other Ocular Implants.
Holekamp, Nancy M; Yaqub, Manejeh; Ranade, Shrirang V; Cantrell, Ronald A; Singh, Sheena; Gazzard, Gus.
Afiliación
  • Holekamp NM; Pepose Vision Institute, Chesterfield, MO, USA. nancy.holekamp@roche.com.
  • Yaqub M; F. Hoffmann-La Roche Ltd, Basel, Switzerland. nancy.holekamp@roche.com.
  • Ranade SV; Genentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.
  • Cantrell RA; Genentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.
  • Singh S; Genentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.
  • Gazzard G; Envision Value & Access, Battersea, London, UK.
Ophthalmol Ther ; 13(9): 2303-2329, 2024 Sep.
Article en En | MEDLINE | ID: mdl-39090513
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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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Ophthalmol Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Ophthalmol Ther Año: 2024 Tipo del documento: Article País de afiliación: Estados Unidos Pais de publicación: Reino Unido