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Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm (RAM-SUB)

Primary Purpose

Aneurysm

Status
Completed
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
subthreshold and threshold laser treatment
Threshold laser treatment
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aneurysm focused on measuring retinal arterial macroaneurysm, laser treatment

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Sites / Locations

  • IRCCS San Raffaele

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

subthreshold laser treatment

threshold laser treatment

Arm Description

Outcomes

Primary Outcome Measures

change in central point thickness

Secondary Outcome Measures

change in visual acuity

Full Information

First Posted
February 22, 2011
Last Updated
February 22, 2011
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01301326
Brief Title
Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm
Acronym
RAM-SUB
Official Title
Pilot Randomized Clinical Trial Comparing Subthreshold Laser Treatment Versus Threshold Laser Treatment for Retinal Arterial Macroaneurysm
Study Type
Interventional

2. Study Status

Record Verification Date
January 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
IRCCS San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
The treatment of RAM is controversial and at present there is no general consensus about the best approach. Spontaneous obliteration of RAM may occur over the follow-up, but the long persistence of blood or subretinal fluid may lead to progressive photoreceptor damage, with consequent irreversible visual impairment. More specifically, the presence of subretinal hemorrhage beneath the fovea leads to a diminished visual function. Treatment is generally indicated for RAM associated with exudative manifestations involving the fovea which do not tend to resolve spontaneously. The most commonly employed approach is direct or indirect laser photocoagulation with visible end-point. Nevertheless, several complications may be associated with conventional threshold laser for macular lesions, including enlargement of laser scar, choroidal neovascularization, and subretinal fibrosis. In addition to these complications, arteriolar obliteration, increased retinal exudation and scarring, with possible retinal traction, have also been reported as possible sequelae of the laser photocoagulation of RAM. Another approach for the treatment of RAM is based on the use of subthreshold laser treatment. Subthreshold laser treatment has been proposed in an attempt to minimize the negative aspects of conventional grid laser photocoagulation and has achieved encouraging results, especially in macular oedema secondary to diabetic retinopathy, proliferative diabetic retinopathy, and branch retinal vein occlusion. The concept underlying the use of subthreshold laser treatment is to decrease the laser damage by reducing the duration of laser exposure and by using a subvisible clinical end point. A micropulse diode laser releases low energy micropulses in order to confine the energy to the RPE cells, with limited protein denaturation, avoiding lateral thermal spreading. Aim of the study is to compare the effects of subthreshold laser treatment to those of threshold laser treatment in patients affected by symptomatic retinal arterial macroaneurysm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm
Keywords
retinal arterial macroaneurysm, laser treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
subthreshold laser treatment
Arm Type
Experimental
Arm Title
threshold laser treatment
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
subthreshold and threshold laser treatment
Other Intervention Name(s)
subthreshold
Intervention Description
subthreshold laser treatment
Intervention Type
Device
Intervention Name(s)
Threshold laser treatment
Other Intervention Name(s)
threshold
Intervention Description
threshold laser treatment
Primary Outcome Measure Information:
Title
change in central point thickness
Time Frame
6 months
Secondary Outcome Measure Information:
Title
change in visual acuity
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: previous treatments for retinal arterial macroaneurysm, any other ocular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francesco Bandello, MD
Organizational Affiliation
Department of Ophthalmology
Official's Role
Study Chair
Facility Information:
Facility Name
IRCCS San Raffaele
City
Milano
State/Province
MI
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
20956278
Citation
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.
Results Reference
background
PubMed Identifier
22395893
Citation
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.
Results Reference
derived

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Subthreshold Laser Treatment Versus Threshold Laser Treatment for Symptomatic Retinal Arterial Macroaneurysm

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