An interventional study of 577-nm PASCAL laser in Macular Telangiectasia, sponsored by The Lowy Medical Research Institute Limited. Completed at 1 site in United States. Open to participants aged 21 Years to 79 Years. Per ClinicalTrials.gov, last updated 2023-03-08.
Sponsored by The Lowy Medical Research Institute Limited · Not applicable, Interventional, and Treatment
This is a two armed Single Masked Pilot Study enrolling participants with Macular Telangiectasia Type 2 who will be randomized to undergo either a subthreshold photothermal treatment or a sham procedure to one eye. The participants will be followed for one year with visits at 1 month, 3 months, 6 months and 12 months post-treatment (laser or sham). Due to the small number of participants enrolled in this study the data will be analyzed by descriptive statistics and exploratory figures. Summary statistics will be produced for study and fellow eyes.
69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.
This study's enrollment of 9 is below the median of 30 across 59 interventional studies indexed under Telangiectasis.
Browse Telangiectasis studies →The Lowy Medical Research Institute Limited is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
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Participant must be able and willing to attend all scheduled visits.
For Participants undergoing optional AOSLO imaging:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: 577-nm PASCAL laser
Device: 577-nm PASCAL laser
The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
To evaluate the safety and tolerability of subthreshold photothermal therapy in patients with MacTel Type 2 as assessed by CTCAE v4.0
Time frame: 3 months post treatment
Change from baseline cone density as measured by confocal adaptive optics (AOSLO)
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
Change in size of ellipsoid zone break area as measured by spectral domain optical coherence tomography (SD-OCT)
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
Development or extension post therapy of areas of deficiency in cones as measured by AOSLO
To evaluate the biological activity of subthreshold photothermal therapy in patients with MacTel Type 2.
Time frame: 1 year
Plan to share: Yes
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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The Lowy Medical Research Institute Limited