Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Retinal Detachment Clinical Trial

Official title:

Rasagiline (Azilect) - Neuroprotection for Macula-off Retinal Detachment

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02068625
• Other study ID #: 178/10
• Secondary ID: 2012DR2022
• Status: Terminated
• Phase: Phase 4
• Start date: September 2010
• Est. completion date: December 31, 2018

Study information

• Verified date: February 2019
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Background

In previous experimental studies neuroprotection by rasagiline has been shown in rds-mice, a model for slow retinal degeneration. It is known from these experiments that rasagiline specifically delays apoptosis, but also modifies inflammation and autophagy. The bioavailability of the drug in the central nervous system is high, and based on the literature is sufficient in the retina.

In retinal detachments the outer layers of the neurosensory retina are deprived of nutrients and degeneration of the photoreceptors occurs fast. This is particularly relevant in the macular area of the retina where the density of photoreceptors is high, such that visual acuity recovery can be significantly limited by photoreceptor loss.

Objective

To assess the neuroprotective effect of oral rasagiline (1mg daily for 7 days) administered perioperatively in patients undergoing surgical retinal detachment repair for central vision involving retinal detachments.

Methods

In this clinical trial, patients suffering from retinal detachments affecting the fovea get randomly assigned to perioperative oral treatment with either rasagiline (1mg) or placebo once daily for 7 days. Pharmacologic treatment is initiated at the time of hospital admission, usually the day before surgery. The main outcome of the study is visual acuity six months after surgical retinal detachment repair. Structural differences of the neurosensory retina between groups will be analysed by optical coherence tomography, a non-invasive imaging method for retinal pathology.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 23
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Dissociative Disorders
• Retinal Detachment

Intervention

Drug:
• Rasagiline
Rasagiline 1mg daily orally for 7 days
• Placebo
Oral treatment with placebo for 7 days

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology, Bern University Hospital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

References & Publications (5)

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. — View Citation

Eigeldinger-Berthou S, Meier C, Zulliger R, Lecaudé 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. — View Citation

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. Epub 2005 Mar 15. — View Citation

Travis GH. Mechanisms of cell death in the inherited retinal degenerations. Am J Hum Genet. 1998 Mar;62(3):503-8. Review. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ETDRS Visual Acuity		6 months
Secondary	Central retinal thickness	Measured by Optical Coherence Tomography (OCT)	6 months
Secondary	Number of patients with side effects		6 months