Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment (NCT04292756) | Clinical Trial Compass
CompletedNot Applicable
Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment
Ukraine63 participantsStarted 2018-03-27
Plain-language summary
The purpose of this study is to determine the effectiveness and safety of triamcinolone acetonide in patients with serous pigment detachment associated with age-related macular degeneration
Who can participate
Age range50 Years – 90 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Able to read (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent form or a family member) and understand the informed consent form and willing to sign the informed consent form.
* Signed informed consent form.
* Men and women ≥ 50 years of age.
* Willing, committed, and able to return for all clinic visits and complete all study-related procedures.
* Naive serous pigment epithelial detachment associated with AMD as defined on FA and OCT.
* Transparent optical media and possibility to mydriasis.
* Best corrected visual acuity at least 20/100 Equivalent of Snellen (ETDRS).
* Absence of signs of CNV, angiomatous retina proliferation, polypoid choriovasculopathy defined on FA and OCT.
Exclusion Criteria:
* Ocular media of insufficient quality to obtain fundus and OCT images in the study eye.
* Previous intravitreal injections of anti-VEGF drugs in the study eye.
* Any injections of corticosteroids (intravitreal, subtenon, subconjunctival or parabulbar) or implantation of medical device in the study eye.
* Ocular inflammation or external ocular inflammation in the study eye.
* Concurrent disease in the study eye that would compromise BCVA or require medical or surgical intervention during the study period.
* Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
* Significant scarring or atrophy in the fovea that indic…
What they're measuring
1
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart
Timeframe: Baseline-Month 12
Trial details
NCT IDNCT04292756
SponsorThe Filatov Institute of Eye Diseases and Tissue Therapy