NCT03332758

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 8, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 13, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2018

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

October 13, 2017

Last Update Submit

August 15, 2018

Conditions

Retinal DetachmentFull Thickness Macular HoleEpiretinal Membrane

Keywords

retinal detachmentinflammasomemacular hole

Outcome Measures

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

    Day of surgery

Secondary Outcomes (1)

  • Difference in inflammasome levels among samples

    Day of surgery

Study Arms (4)

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

Pars plana vitrectomyPROCEDURE

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

ERM treated with vitrectomyMacular holes treated with vitrectomyRD treated with vitrectomy
External drainagePROCEDURE

Standard of care treatment for retinal detachment.

RD treated with external drainage

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patient of the Wills Eye Hospital Retina service and Mid-Atlantic Retina offices.
  • Volunteer patients age 18 years and older.
  • Healthy enough to participate in the study.
  • Willing and able to consent to participation in the study.
  • 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

You may not qualify if:

  • Presence of tractional retinal detachment
  • History of trauma
  • Presence of proliferative vitreoretinopathy
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MidAtlantic Retina-Wills Eye Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

  • 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.

    PMID: 23994436BACKGROUND

  • 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.

    PMID: 25906154BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Vitreous fluid and subretinal fluid

MeSH Terms

Conditions

Retinal DetachmentEpiretinal MembraneRetinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Allen C Ho, MD

    MidAtlantic Retina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 13, 2017

First Posted

November 6, 2017

Study Start

September 8, 2017

Primary Completion

April 10, 2018

Study Completion

May 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

US(1)