Health TrialsbyHealthPanel

MacuTherm Performance Study in Patients With iAMD

ConditionIntermediate AMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorOD-OS MacuTherm GmbH

About this trial

The goal of this study is to demonstrate that photothermal therapy with the individually dosed treatment plan proposed by Macula Explorer delivered safely by Navilas® Laser System effectively improves the life of photoreceptors and reduces the progression of intermediate Age-related Macular Degeneration (iAMD) and preserves photoreceptors shown by Ellipsoid Zone Integrity (EZI).

Participants will be randomized to either Treatment or Control Group. There will be 12 visits, monthly for the first 3 months, then quarterly until the end of the study after 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male, female, or diverse

Age of 60 to 90 years old

At least 3 large drusen (diameter > 125 μm) within the inner ring of 3mm diameter of the ETDRS Grid centered on the fovea (with or without reticular pseudodrusen (RPE))

Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and/or

Disqualifiers

Presence of late-stage AMD, neovascular (nAMD, active or fibrotic) or geographic atrophy (GA)

Maculopathies showing only pseudodrusen

Any systemic medication known to be toxic to the lens, retina or optic nerve

Any intraocular surgery within 6 months prior to study inclusion (except uncomplicated cataract surgery > 3 months)

Trial design

Design model

Parallel

Treatments tested in this trial

  • photothermal therapy

    Device

    Patients receive individualized photothermal therapy in the study eye

  • Sham treatment

    Device

    Patients receive sham treatment in the study eye

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Treatment GroupExperimental treatment 1 intervention
Group B: Control GroupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI).

It is reached if at 12 months the EZI change from baseline is significantly better in the Treatment Group than in the Control Group.

Time frame
12 months

Secondary outcomes

1

Change in eyes of Treatment Group compared to eyes in Control Group compared to baseline to determine progression of Drusen within ETDRS sector (<6mm)

Time frame
24 months
2

Rate of eyes converting to geographic atrophy

Time frame
24 months
3

Rate of eyes converting to active exudative nAMD

Time frame
24 months
4

Loss in BCVA of > 3 lines compared to baseline

Time frame
24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

OD-OS MacuTherm GmbH

Lead sponsor

Source ClinicalTrials.gov
Apply now