N/A
Completed N=19
Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Macular Degeneration · Retinal Drusen
Source: ClinicalTrials.gov NCT02569892 ↗
Enrolled (actual)
19
Serious AEs
0.0%
Results posted
May 2021
Primary outcomePrimary: Change in Macular Drusen Volume — 0.05; 0.11; 20.0; 9.0 mm^3
Summary
This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Macular Drusen Volume |
0.05; 0.11; 20.0; 9.0; 42.2; 27.2 | — |
| SECONDARY Change in Visual Acuity |
81.7; 79.4; -0.7; -3.4; -2.7; -0.9 | — |
| SECONDARY Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Older than 60 years of age.
- Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
- Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
- Able to give an informed consent.
Exclusion Criteria
- Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
- Previous macular laser treatment.
- Any previous ocular condition that may be associated with a risk of developing macular oedema.
- Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
- Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
- Important known allergies to sodium fluorescein dye used in angiography.
- Ocular or periocular infections.
- Planned intra-ocular surgery within one year.
- Patient is unavailable for follow-up visits.
Data sourced from ClinicalTrials.gov (NCT02569892). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.