Status:
COMPLETED
Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment
Lead Sponsor:
The Filatov Institute of Eye Diseases and Tissue Therapy
Collaborating Sponsors:
Odessa National Medical University
Mykolaiv Region Ophthalmogical Hospital
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50-90 years
Phase:
NA
Brief 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
Detailed Description
The purpose of this study is to determine the effectiveness and safety of triamcinolone acetonide in patients with serous pigment epithelial detachment associated with age-related macular degeneration...
Eligibility Criteria
Inclusion
- 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
- 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 indicates substantial irreversible vision loss in the study eye.
- Evidence at examination of infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye or current treatment for serious systemic infection.
- Vitreomacular traction or traction retinal detachment, epiretinal membrane in study eye.
- Any iris neovascularization and/or vitreous hemorrhage in either eye.
- Uncontrolled glaucoma, or previous filtration surgery in either eye.
- Maсular hole.
- Any prior treatment with photodynamic therapy in the study eye.
- Cataract surgery within 3 months prior to Day 1 in the study eye.
- Yttrium-aluminum-garnet laser capsulotomy within 2 months prior to Day 1 in the study eye.
- Any other intraocular surgery within 3 months prior to Day 1 in the study eye.
- History of vitreoretinal surgery and/or scleral buckle surgery in the study eye.
- Previous assignment to treatment during this study.
- Uncontrolled hypertension.
- History of cerebrovascular disease or myocardial infarction within 6 months prior to Baseline/Day 1.
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect interpretation of the results of the study, or renders the subject at high risk from treatment complications.
- Women of childbearing potential without contraception, women who intend to breastfeed during the study. All subjects (both men and women) of childbearing potential who are unwilling to use adequate birth control measures during the course of the study.
- Renal failure requiring dialysis or renal transplant.
- Participation in an investigational study within 30 days prior to Screening/Visit 1 that involved treatment with any drug (excluding vitamins and minerals) or device.
- Known serious allergy to the fluorescein sodium for injection in angiography or Verteporfin.
- Inability to obtain fundus photographs or fluorescein angiograms of sufficient quality.
Key Trial Info
Start Date :
March 27 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT04292756
Start Date
March 27 2018
End Date
December 31 2020
Last Update
August 23 2022
Active Locations (4)
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1
Odessa National Medical University
Odesa, Please Select, Ukraine, 65061
2
CPUkraine
Kyiv, Ukraine
3
Mykolaiv Region Ophthalmogical Hospital
Mykolaiv, Ukraine, 54000
4
The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, Ukraine, 65061