NCT00940407

Brief Summary

The purpose of this study is to evaluate clinical outcomes of Photobiomodulation treatment on patients with dry Age Related Macular Degeneration (AMD). Photobiomodulation is the use of non thermal, non laser light of specific wavelengths and energy directly on the eye to improve retinal function and delay AMD progression. This is a prospective 2 center phase 2 clinical pilot study with no placebo group.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
2 countries

2 active sites

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

January 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

November 18, 2011

Status Verified

November 1, 2011

Enrollment Period

2.6 years

First QC Date

July 14, 2009

Last Update Submit

November 16, 2011

Conditions

Nonexudative Age-related Macular Degeneration

Keywords

dry AMDlight treatmentARMDphotobiomodulationmaculareye diseaseageing eye disease

Outcome Measures

Primary Outcomes (1)

  • Change in ETDRS Visual Acuity

    prior to intervention and 3 monthly intervals to 1 year

Secondary Outcomes (2)

  • change in contrast sensitivity

    prior to intervention and 3 monthly to 1 year

  • changes in retinal function parameters from Nidek MP1 assessment

    prior to intervention and 3 monthly to 1 year

Interventions

Photobiomodulation (Gentlewaves, Warp 10)DEVICE

Two separate light emitting devices that are already approved for other indications are used. Treatment will consist of 18 treatments lasting approximately two minutes per treatment.

Also known as: Gentlewaves, Warp 10

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients of both genders aged 50 years inclusive and over
  • patients must have DRY macular degeneration in the study eye
  • best corrected visual acuity between 20/40 and 20/200
  • patients must be competent to sign and have signed a consent form before study entry

You may not qualify if:

  • visually significant cataracts
  • presence of a visually significant posterior capsule if prior cataract has been performed
  • any visually significant disease process in any ocular structure that would affect vision unrelated to macular degeneration
  • a patient can be enrolled if only one of their eyes meets the criteria
  • patients with severe clinically significant medical disease or unstable medical conditions including cardiovascular, hepatic, renal, neurological, endocrine, gastrointestinal, CNS or life threatening disease or current malignancy at the discretion of the investigators
  • patients who are non-ambulatory or bed ridden
  • female patients who are pregnant or of childbearing potential as the effects of PBM on the developing fetus are unknown
  • patients with a history of epilepsy
  • patients with a history of alcohol, drug or substance abuse in the past 6 months
  • patients deemed uncooperative or non compliant with the requirements of the protocol
  • patients who have received any investigational drug or treatment within 30 days prior to study entry
  • patients who are not competent to understand and sign consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr Robert Dotson

Oak Ridge, Tennessee, 37830, United States

Location

Dr Graham Merry

Toronto, Ontario, M5R 1C4, Canada

Location

MeSH Terms

Conditions

Eye Diseases

Interventions

Low-Level Light Therapy

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Officials

  • Graham F Merry, MBBS; LMCC

    Dr. Graham Merry

    PRINCIPAL INVESTIGATOR

  • Robert Dotson, M.D.

    Dr. Robert Dotson

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 16, 2009

Study Start

January 1, 2009

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

November 18, 2011

Record last verified: 2011-11

Locations

US(1)CA(1)