NCT02068625

Brief Summary

This randomised, double-blind, placebo-controlled clinical trial investigates the neuroprotective effect of rasagiline in patients suffering from a retinal detachment affecting central vision. Based on results from a study in mice suffering from retinal degeneration, the investigators hypothesize that rasagiline delays neurodegeneration in the retina and improves visual acuity outcomes after retinal detachment surgery. Rasagiline is a second-generation propargylamine with neuroprotective properties modulating the caspase-dependent pathway of programmed cell death.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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 1, 2010

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2014

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

8.3 years

First QC Date

February 19, 2014

Last Update Submit

February 18, 2019

Conditions

Retinal Detachment

Keywords

retinal detachmentrasagilineoptical coherence tomographyvisual acuityneuroprotectionazilect

Outcome Measures

Primary Outcomes (1)

  • ETDRS Visual Acuity

    6 months

Secondary Outcomes (2)

  • Central retinal thickness

    6 months

  • Number of patients with side effects

    6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Patients getting perioperative oral treatment with rasagiline (1mg daily) for 7 days

Drug: Rasagiline

Control

PLACEBO COMPARATOR

Patients getting perioperative oral treatment with placebo for 7 days

Drug: Placebo

Interventions

RasagilineDRUG

Rasagiline 1mg daily orally for 7 days

Treatment
PlaceboDRUG

Oral treatment with placebo for 7 days

Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Rhegmatogenous retinal detachment
  • Central vision affected for less than 72 hours
  • Pseudophakic
  • Age 18 or over
  • Not participating in other clinical trials
  • Willing to attend follow-up visits
  • Written informed consent

You may not qualify if:

  • Phakic
  • Narrow angle glaucoma
  • Previous intraocular surgery other than cataract operation
  • Retinal disease
  • Concurrent treatment with MAO inhibitors
  • Pregnancy
  • Malignant arterial hypertension
  • Liver or kidney failure
  • Life-threatening or malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

  • Eigeldinger-Berthou S, Meier C, Zulliger R, Lecaude S, Enzmann V, Sarra GM. Rasagiline interferes with neurodegeneration in the Prph2/rds mouse. Retina. 2012 Mar;32(3):617-28. doi: 10.1097/IAE.0b013e31821e2070.

    PMID: 21878836BACKGROUND

  • Youdim MB, Bar Am O, Yogev-Falach M, Weinreb O, Maruyama W, Naoi M, Amit T. Rasagiline: neurodegeneration, neuroprotection, and mitochondrial permeability transition. J Neurosci Res. 2005 Jan 1-15;79(1-2):172-9. doi: 10.1002/jnr.20350.

    PMID: 15573406BACKGROUND

  • Travis GH. Mechanisms of cell death in the inherited retinal degenerations. Am J Hum Genet. 1998 Mar;62(3):503-8. doi: 10.1086/301772. No abstract available.

    PMID: 9497269BACKGROUND

  • Cook B, Lewis GP, Fisher SK, Adler R. Apoptotic photoreceptor degeneration in experimental retinal detachment. Invest Ophthalmol Vis Sci. 1995 May;36(6):990-6.

    PMID: 7730033BACKGROUND

  • Eliash S, Shteter N, Eilam R. Neuroprotective effect of rasagiline, a monoamine oxidase-B inhibitor, on spontaneous cell degeneration in a rat model. J Neural Transm (Vienna). 2005 Aug;112(8):991-1003. doi: 10.1007/s00702-004-0254-4. Epub 2005 Mar 15.

    PMID: 15765264BACKGROUND

MeSH Terms

Conditions

Retinal Detachment

Interventions

rasagiline

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Sebastian Wolf

    Department of Ophthalmology, Bern University Hospital

    STUDY CHAIR

  • Andreas Ebneter

    Department of Ophthalmology, Bern University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2014

First Posted

February 21, 2014

Study Start

September 1, 2010

Primary Completion

December 31, 2018

Study Completion

December 31, 2018

Last Updated

February 20, 2019

Record last verified: 2019-02

Locations

CH(1)