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CompletedNCT03332758Updated Aug 17, 2018

Inflammasomes in Cell Death in FTMH, ERM, and RRD

An observational study in Retinal Detachment, Full Thickness Macular Hole and Epiretinal Membrane, sponsored by Allen C. Ho, MD. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-08-17.

Sponsored by Allen C. Ho, MD · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
41
Ages
18 Years and older
Sex
All
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Study summary

Prospective study evaluating the role of inflammasomes in cell death in retinal detachment, full thickness macular hole, and epiretinal membrane. The investigators are collecting vitreous and subretinal fluid samples from patients with these conditions and evaluating activity of the inflammasome pathway with established assays.

Read the detailed description

Photoreceptor cell death is the main cause of vision loss in many retinal disorders, including retinal detachment (RD). While apoptosis is the most studied form of cell death, the investigators believe patients with RDs may have photoreceptor cell death from a distinct pathway of programmed cell death called pyroptosis which also involves an inflammatory response. Pyroptosis is distinct from apoptosis in that it requires the activation of a protein oligomer complex called an inflammasome. The inflammasome is a pro-inflammatory complex composed of apoptosis-associated speck-like protein containing a CARD (ASC), nucleotide-binding oligomerization domain-containing protein (NOD)-like receptor (NLR) family or pyrin and HIN domain (PYHIN) family, and caspase-11. Activation of the inflammasome complex leads to activation of capspase 1 proteolytic activity to cleave and synthesize IL-1β and IL-18. As such the investigators believe inflammasomes and its activated products may play a strong role in the inflammatory and cell death pathway for photoreceptor cells in human retina. Studies using animal models of RD have already confirmed the presence of IL-1β activation2, however, the presence of IL-18 needs to be confirmed in human detached retinas. In a study performed on the detached retinas in mice, researchers were able to show activation of inflammasomes leading to photoreceptor cell death. While researchers are unable to determine the cellular source of the inflammasomes they were able to show that activation inflammasomes closely follows animal models. Currently there is no method to rescue photoreceptors cells from the mediated cell death pathway despite surgical intervention. Thus, current visual prognosis and prevention of further photoreceptor loss due to a RD is likely dependent on the time of surgical intervention before further detachment and further cell death can occur. As such, the purpose of this current study is to confirm the presence of inflammasome activation as well as the synthesis of its products, IL-1β and IL-18, in patients with rhegmatogenous retinal detachments. Both inflammasomes and its products IL-1β and IL-18 may be involved in cell pyroptosis, a programmed cell death distinct from apoptosis. Due to a lack of treatment for the rescue of photoreceptor cells from cell death after a retinal detachment, this study can provide novel strategies to inhibit cell death.

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Conditions studied

  • Retinal Detachment
  • Full Thickness Macular Hole
  • Epiretinal Membrane

Keywords

  • retinal detachment
  • inflammasome
  • macular hole
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In context

Retinal Detachment

199 studies on the registry are indexed under Retinal Detachment; 29 are open to participants now.

This study's enrollment of 41 is below the median of 60 across 58 observational studies indexed under Retinal Detachment.

Browse Retinal Detachment studies →

Lead sponsor

This is the only study on the registry with Allen C. Ho, MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adults with retinal detachment, macular hole, or epiretinal membrane.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient of the Wills Eye Hospital Retina service and Mid-Atlantic Retina offices.
  2. Volunteer patients age 18 years and older.
  3. Healthy enough to participate in the study.
  4. Willing and able to consent to participation in the study.
  5. Diagnosis of rhegmatogenous retinal detachment treated with external drainage of subretainl fluid, rhegmatogenous retinal detachment treated with pars plana vitrectomy, or full thickness macular hole treated with pars plana vitrectomy

Exclusion criteria

Exclusion Criteria:

  1. Presence of tractional retinal detachment
  2. History of trauma
  3. Presence of proliferative vitreoretinopathy
  4. History of prior retinal detachment repair or any prior retina surgery or laser treatment e. Any preexisting retinal disease (including diabetic retinopathy, age related macular degeneration, retinal vein or artery occlusion, other retinal vascular disease, inherited retinal degeneration, uveitis)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
41 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • RD treated with vitrectomy

    Vitreous fluid from retinal detachment treated with pars plana vitrectomy

    Procedure: Pars plana vitrectomy

  • RD treated with external drainage

    Subretinal fluid from retinal detachment treated with external drainage.

    Procedure: External drainage

  • Macular holes treated with vitrectomy

    Vitreous fluid from patients treated for macular hole

    Procedure: Pars plana vitrectomy

  • ERM treated with vitrectomy

    Vitreous fluid from patients treated for epiretinal membrane

    Procedure: Pars plana vitrectomy

Interventions

  • ProcedurePars plana vitrectomy

    Standard of care treatment for retinal detachment, macular hole, or epiretinal membrane.

  • ProcedureExternal drainage

    Standard of care treatment for retinal detachment.

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What researchers measure

Primary outcomes

  1. Presence of inflammasomes and their active products

    Presence of inflammasomes and their active products in patients with retinal detachment treated with vitrectomy or external drainage, macular holes treated with vitrectomy, and epiretinal membranes treated with vitrectomy

    Time frame: Day of surgery

Secondary outcomes

  1. Difference in inflammasome levels among samples

    Difference in inflammasome pathway activation between retinal detachment, macular hole, and epiretinal membrane samples

    Time frame: Day of surgery

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Study locations

1 site
  • MidAtlantic Retina-Wills Eye Hospital
    Philadelphia, Pennsylvania 19107, United States
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References and documents

Publications

  • Murakami Y, Notomi S, Hisatomi T, Nakazawa T, Ishibashi T, Miller JW, Vavvas DG. Photoreceptor cell death and rescue in retinal detachment and degenerations. Prog Retin Eye Res. 2013 Nov;37:114-40. doi: 10.1016/j.preteyeres.2013.08.001. Epub 2013 Aug 28. PubMed 23994436 ↗
  • Kataoka K, Matsumoto H, Kaneko H, Notomi S, Takeuchi K, Sweigard JH, Atik A, Murakami Y, Connor KM, Terasaki H, Miller JW, Vavvas DG. Macrophage- and RIP3-dependent inflammasome activation exacerbates retinal detachment-induced photoreceptor cell death. Cell Death Dis. 2015 Apr 23;6(4):e1731. doi: 10.1038/cddis.2015.73. PubMed 25906154 ↗

Individual participant data

Plan to share: Undecided — manuscript under development

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03332758
Lead sponsor
Allen C. Ho, MD
Collaborators
Mid Atlantic Retina
Responsible party
Allen C. Ho, MD (Principal Investigator, Wills Eye) — Sponsor-investigator
First posted
Nov 6, 2017
Start date
Sep 8, 2017
Primary completion
Apr 10, 2018
Completion
May 1, 2018
Last update
Aug 17, 2018

Study contacts

Allen C Ho, MD
principal investigator · MidAtlantic Retina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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