Evidence map›Paper›PMID 27457255›Full record

Trial reportAmerican journal of ophthalmology2016

Long-term Follow-up of Patients With Retinitis Pigmentosa Receiving Intraocular Ciliary Neurotrophic Factor Implants.

David G Birch, Lea D Bennett, Jacque L Duncan, Richard G Weleber, Mark E Pennesi

Open access · greenAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 67 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
67citing papers in PubMed, 2 pooled it
6.8field-weighted citation impact, top 3% of its field
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

67 citing papers in PubMed, 2 syntheses or guidelines pooled it, 107 citations in OpenAlex.

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  18. Retinitis Pigmentosa: Current Clinical Management and Emerging Therapies.International journal of molecular sciences · 2023
    Review
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  20. Review

7 more citing papers are in PubMed but not listed here.

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

5 authors at 4 institutions in 1 country.

David G BirchRetina Foundation of the Southwest, Dallas, Texas; Department of Ophthalmology, UT Southwestern Medical Center, Dallas, Texas. Electronic address: dbirch@retinafoundation.org.
Lea D BennettRetina Foundation of the Southwest, Dallas, Texas.
Jacque L DuncanDepartment of Ophthalmology, University of California, San Francisco, California.
Richard G WeleberOregon Health & Science University Casey Eye Institute, Portland, Oregon.
Mark E PennesiOregon Health & Science University Casey Eye Institute, Portland, Oregon.
Oregon Health & Science University · USRetina Foundation of the Southwest · USSouthwestern Medical Center · USUniversity of California, San Francisco · US

Funding

MEASURES OF HUMAN RECEPTOR AND POST RECEPTOR ACTIVITYR01EY009076 · NEI · COLUMBIA UNIV NEW YORK MORNINGSIDE · PI BIRCH, DAVID G, HOOD, DONALD C. · 1991 to 2021
$8.3M
Phase 2 Study of CNTF on Photoreceptor Structure in Retinitis PigmentosaR01FD004100 · FDA · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI DUNCAN, JACQUE LYNNE · 2012 to 2018
$1.4M
Serotonin Receptor Modulation of Neurotrophic Factors in the RetinaK08EY021186 · NEI · OREGON HEALTH & SCIENCE UNIVERSITY · PI PENNESI, MARK E · 2011 to 2015
$824k
FDA HHS R01 FD004100NEI NIH HHS K08 EY021186NEI NIH HHS R01 EY009076
6 · The paper itself

Abstract

purposeTo evaluate the long-term efficacy of ciliary neurotrophic factor delivered via an intraocular encapsulated cell implant for the treatment of retinitis pigmentosa.

designLong-term follow-up of a multicenter, sham-controlled study.

methodsThirty-six patients at 3 CNTF4 sites were randomly assigned to receive a high- or low-dose implant in 1 eye and sham surgery in the fellow eye. The primary endpoint (change in visual field sensitivity at 12 months) had been reported previously. Here we measure long-term visual acuity, visual field, and optical coherence tomography (OCT) outcomes in 24 patients either retaining or explanting the device at 24 months relative to sham-treated eyes.

resultsEyes retaining the implant showed significantly greater visual field loss from baseline than either explanted eyes or sham eyes through 42 months. By 60 months and continuing through 96 months, visual field loss was comparable among sham-treated eyes, eyes retaining the implant, and explanted eyes, as was visual acuity and OCT macular volume.

conclusionsOver the short term, ciliary neurotrophic factor released continuously from an intravitreal implant led to loss of total visual field sensitivity that was greater than the natural progression in the sham-treated eye. This additional loss of sensitivity related to the active implant was reversible when the implant was removed. Over the long term (60-96 months), there was no evidence of efficacy for visual acuity, visual field sensitivity, or OCT measures of retinal structure.

Indexed as

Drug Delivery SystemsAdultAgedCiliary Neurotrophic FactorElectroretinographyFemaleFollow-Up StudiesHumansMaleRetinaRetinitis PigmentosaTomography, Optical CoherenceVisual AcuityVisual FieldsVisual Field TestsCiliary Neurotrophic Factor

Identifiers

PMID27457255
PMCPMC5056139
OpenAlexW2501579558

What OpenQuestion holds

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Registered trials

None linked

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.