Evidence map›Paper›PMID 25653883›Full record

ArticleTranslational vision science & technology2014

Implantable MicroPump for Drug Delivery in Patients with Diabetic Macular Edema.

Mark Humayun, Arturo Santos, Juan Carlos Altamirano, Ramiro Ribeiro, Roberto Gonzalez, Alejandro de la Rosa, Jason Shih, Changling Pang, Fukang Jiang, Philip Calvillo and 3 more

Abstract read
In one paragraph

Article in Translational vision science & technology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing 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

29 citing papers in PubMed.

  1. Review
  2. Review
  3. Progress in Ocular Drug Delivery: Challenges and Constraints.Handbook of experimental pharmacology · 2024
    Article
  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. In-Vivo Microsystems: A Review.Sensors (Basel, Switzerland) · 2020
    Review
  16. Review
  17. Article
  18. The Evolving Treatment of Diabetic Retinopathy.Clinical ophthalmology (Auckland, N.Z.) · 2020
    Review
  19. Review
  20. 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

13 authors.

Mark HumayunDepartment of Ophthalmology, Keck School of Medicine of the University of Southern California, Los Angeles, CA, USA.
Arturo SantosMedical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
Juan Carlos AltamiranoMedical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
Ramiro RibeiroReplenish, Inc., Pasadena, CA, USA ; Department of Ophthalmology, Federal University of São Paulo, São Paulo, Brazil.
Roberto GonzalezMedical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
Alejandro de la RosaMedical School, Technologic University of Monterrey, Guadalajara, Mexico ; Centro de Retina Médica y Quirúrgica SC, Guadalajara, Mexico.
Jason ShihReplenish, Inc., Pasadena, CA, USA.
Changling PangReplenish, Inc., Pasadena, CA, USA.
Fukang JiangReplenish, Inc., Pasadena, CA, USA.
Philip CalvilloReplenish, Inc., Pasadena, CA, USA.
John HuculakAltaviz, LLC, Lake Forest, CA, USA.
Jenna ZimmermanReplenish, Inc., Pasadena, CA, USA.
Sean CaffeyReplenish, Inc., Pasadena, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo demonstrate the safety and surgical feasibility of the first-in-man ocular implant of a novel Posterior MicroPump Drug Delivery System (PMP) in patients with diabetic macular edema (DME) and to report on the device capabilities for delivering a programmable microdose.

methodsThis was a single center, single arm, open-label, prospective study. Eleven patients with DME and visual acuity equal to or worse than 20/40 were included. The PMP prefilled with ranibizumab was implanted into the subconjunctival space. After implantation, the PMP was wirelessly controlled to deliver a programmed microdose. Comprehensive ophthalmic exams and optical coherence tomography were performed biweekly for 90 days. At the end of the study, the PMP was explanted and the subjects thereafter received standard of care for DME (i.e., laser or intravitreal injections).

resultsAll 11 surgical implantations were without complications and within the skill sets of a retinal surgeon. No serious adverse events occurred during the follow-up period. At no point were visual acuity and central foveal thickness worse than baseline in the implanted eye. The PMP delivered the programmed ranibizumab dosage in seven subjects. The remaining four patients received a lower than target dose, and the treatment was complemented with standard intravitreal injection.

conclusionsThis study demonstrates the first-in-man safety of the Replenish MicroPump implant for a period of 90 days and its capability to deliver a microdose into the vitreous cavity. Further studies to enable longer-term safety and to demonstrate the feasibility of multiple programmable drug delivery are necessary.

Indexed as

age-related macular degenerationdiabetic macular edemadrug deliverymacular degenerationocular drug delivery

Identifiers

PMID25653883
PMCPMC4315583

What OpenQuestion holds

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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.