Evidence map›Paper›PMID 39090513›Full record

ReviewOphthalmology and therapy2024

Systematic Literature Reviews Comparing the Long-Term Safety Outcomes for the Port Delivery System with Ranibizumab (PDS) Versus Other Ocular Implants.

Nancy M Holekamp, Manejeh Yaqub, Shrirang V Ranade, Ronald A Cantrell, Sheena Singh, Gus Gazzard

Abstract readReview
In one paragraph

Review in Ophthalmology and therapy, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nancy M HolekampPepose Vision Institute, Chesterfield, MO, USA. nancy.holekamp@roche.com.ORCID http://orcid.org/0000-0001-7850-8515
Manejeh YaqubGenentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.ORCID http://orcid.org/0009-0008-1088-8863
Shrirang V RanadeGenentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.ORCID http://orcid.org/0000-0002-9457-2477
Ronald A CantrellGenentech, Inc., a Member of the Roche Group, South San Francisco, CA, USA.ORCID http://orcid.org/0000-0001-6806-6071
Sheena SinghEnvision Value & Access, Battersea, London, UK.ORCID http://orcid.org/0000-0001-9321-7599
Gus GazzardInstitute of Ophthalmology, University College London, London, UK.ORCID http://orcid.org/0000-0003-1982-5005

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo 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.

methodsSystematic 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).

resultsSixteen 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.

conclusionsThe 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 registrationPROSPERO international prospective register of systematic reviews: CRD5202234129, CRD42022343129.

Indexed as

Age-related macular degenerationDiabetic macular edemaDiabetic retinopathyOcular implantsPort Delivery System with ranibizumab (PDS)Retinal diseases

Identifiers

PMID39090513
PMCPMC11341515

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.