NCT01301326

Brief Summary

Best treatment option of retinal arterial macroaneurysm is still controversial. A recent publication has shown that subthreshold laser treatment can be beneficial in improving visual acuity in eyes with symptomatic retinal arterial macroaneurysm. Aim of the study is to compare the effects of subthreshold laser treatment and threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

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

April 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2011

Completed
Last Updated

February 23, 2011

Status Verified

January 1, 2011

Enrollment Period

10 months

First QC Date

February 22, 2011

Last Update Submit

February 22, 2011

Conditions

Aneurysm

Keywords

retinal arterial macroaneurysmlaser treatment

Outcome Measures

Primary Outcomes (1)

  • change in central point thickness

    6 months

Secondary Outcomes (1)

  • change in visual acuity

    6 months

Study Arms (2)

subthreshold laser treatment

EXPERIMENTAL
Device: subthreshold and threshold laser treatment

threshold laser treatment

ACTIVE COMPARATOR
Device: Threshold laser treatment

Interventions

subthreshold and threshold laser treatmentDEVICE

subthreshold laser treatment

Also known as: subthreshold
subthreshold laser treatment
Threshold laser treatmentDEVICE

threshold laser treatment

Also known as: threshold
threshold laser treatment

Eligibility Criteria

Age35 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Retinal arterial macroaneurysm, exudative manifestations involving the fovea (including: subretinal/intraretinal fluid, and/or hard exudates, and/or hemorrhages), best corrected visual acuity worse than 20/80 Snellen equivalent, corresponding to 0.6 LogMAR

You may not qualify if:

  • previous treatments for retinal arterial macroaneurysm, any other ocular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (2)

  • Parodi MB, Iacono P, Ravalico G, Bandello F. Subthreshold laser treatment for retinal arterial macroaneurysm. Br J Ophthalmol. 2011 Apr;95(4):534-8. doi: 10.1136/bjo.2009.175547. Epub 2010 Oct 17.

    PMID: 20956278BACKGROUND

  • Battaglia Parodi M, Iacono P, Pierro L, Papayannis A, Kontadakis S, Bandello FM. Subthreshold laser treatment versus threshold laser treatment for symptomatic retinal arterial macroaneurysm. Invest Ophthalmol Vis Sci. 2012 Apr 2;53(4):1783-6. doi: 10.1167/iovs.11-8772.

    PMID: 22395893DERIVED

MeSH Terms

Conditions

AneurysmRetinal Arterial Macroaneurysm

Interventions

Speech Reception Threshold Test

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesHypertensive RetinopathyRetinal DiseasesEye DiseasesHypertension

Intervention Hierarchy (Ancestors)

Audiometry, SpeechAudiometryHearing TestsDiagnostic Techniques, OtologicalDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Francesco Bandello, MD

    Department of Ophthalmology

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 22, 2011

First Posted

February 23, 2011

Study Start

April 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 23, 2011

Record last verified: 2011-01

Locations

IT(1)