Evidence map›Paper›PMID 40192619›Full record

ArticleTranslational vision science & technology2025

Structural Updates to the Implant and Refill Needle of the Port Delivery Platform.

Dante J Pieramici, Peter A Campochiaro, Margaret Chang, Ian Pearce, Carl D Regillo, Shamika Gune, Nancy Holekamp, Carlos Quezada-Ruiz, Shrirang V Ranade, Natasha Singh and 2 more

Abstract read
In one paragraph

Article in Translational vision science & technology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Ranibizumab port delivery system for neovascular age-related macular degeneration: Current evidence and surgical considerations.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Review
  2. Review
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

12 authors.

Dante J PieramiciCalifornia Retina Consultants, California Retina Research Foundation, Retina Consultants of America, Santa Barbara, CA, USA.
Peter A CampochiaroThe Wilmer Eye Institute, Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Margaret ChangRetinal Consultants Medical Group, Sacramento, CA, USA.
Ian PearceSt. Paul's Eye Unit, Royal Liverpool University Hospital, Liverpool, UK.
Carl D RegilloWills Eye Hospital, Thomas Jefferson University, Mid Atlantic Retina, Philadelphia, PA, USA.
Shamika GuneGenentech, Inc., South San Francisco, CA, USA.
Nancy HolekampF. Hoffmann-La Roche Ltd., Basel, Switzerland.
Carlos Quezada-RuizGenentech, Inc., South San Francisco, CA, USA.
Shrirang V RanadeGenentech, Inc., South San Francisco, CA, USA.
Natasha SinghGenentech, Inc., South San Francisco, CA, USA.
Geoffrey WiseGenentech, Inc., South San Francisco, CA, USA.
Joshua HorvathGenentech, Inc., South San Francisco, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Purpose: The purpose of this study was to report the impact of component-level changes and manufacturing process improvements on septum durability in the ocular implant of the Port Delivery Platform (PD-P), more commonly known as the Port Delivery System with ranibizumab (PDS) with its current formulation. Methods: Laboratory tests were conducted to determine (1) the bond strength of the septum to the overmold, (2) the amount of force utilized for the refill needle to puncture the septum, and (3) septum durability over 50 years. To simulate multiple refill-exchanges over long-term clinical use, implants were aged at elevated temperature in saline and the septum was repetitively punctured at random locations using the refill needle every 3.5 days, simulating 6 months of use. Results: Updates to the septum-overmold interface of the implant and manufacturing process improvements doubled the bond strength between the overmold and septum (1.2 N to 2.4 N). Light lubrication of the refill needle reduced needle insertion force into the septum by >50% (1 N to 0.4 N). Together, these modifications increased long-term septum durability, with no septum dislodgements being observed after over 50 years of simulated use. Conclusions: Structural updates to the PD-P implant and refill needle have met and exceeded performance specifications, mitigating the risk of future septum dislodgement in the updated product. Translational Relevance: Structural updates to the PD-P implant and refill needle resulted in the ability to withstand the equivalent of over 50 years of simulated use without septum dislodgement and should improve the longevity of the device in clinical use.

Indexed as

Drug Delivery SystemsNeedlesRanibizumabAngiogenesis InhibitorsEquipment DesignHumansAngiogenesis InhibitorsRanibizumab

Identifiers

PMID40192619
PMCPMC11980950

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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.