NCT05507840

Brief Summary

The study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
121

participants targeted

Target at P50-P75 for not_applicable

Timeline
19mo left

Started Dec 2022

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress69%
Dec 2022Dec 2027

First Submitted

Initial submission to the registry

June 30, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 12, 2022

Status Verified

October 1, 2022

Enrollment Period

4 years

First QC Date

June 30, 2022

Last Update Submit

October 11, 2022

Conditions

PhotobiomodulationAge-Related Macular Degeneration

Keywords

choroidal neovascular membrane

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients that develope late AMD in the study eye compared with control after 3 years of follow-up

    3 years

Study Arms (2)

Intervention

EXPERIMENTAL

Near or infra red light provided by the Valeda machine will be applied in the intervention eye

Device: Valeda machine

Control

SHAM COMPARATOR

Light with very low intensity provided by the same Valeda machine will be applied in the control eye

Device: Valeda machine

Interventions

Valeda machineDEVICE

Photobiomodulation treatment with Valeda machine will be applied every six months for 2 years in patients with dry age related macula degeneration.

ControlIntervention

Eligibility Criteria

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

You may qualify if:

  • patients with dry AMD in the study eye and wet AMD in the control eye

You may not qualify if:

  • Geographic atrophy of the central macular region at enrolment
  • Previous/ active wet AMD in the study eye
  • A history of epilepsy
  • Retinal diseases apart from AMD
  • Significant media opacities
  • Cataracts worse than grade 2 (LOCS III classification)
  • Change in AREDS 2 supplements (vitamins) 1 month before the study and during the study trial was allowed.
  • Ongoing systemic medications that are photosensitizing (e.g. tetracyclins)
  • Systemic medications during the last 6 months that can cause deposits in the macular region (hydroxychloroquine, amiodarone)
  • Unable to give informed consent
  • Unable to cooperate with the treatment and follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD dr. med.

Study Record Dates

First Submitted

June 30, 2022

First Posted

August 19, 2022

Study Start

December 1, 2022

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 12, 2022

Record last verified: 2022-10