Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment (COAST_UA_AMD)

Safety and Effectiveness of Triamcinolone Acetonide in Patients With Serous Pigment Detachment Associated With Age-Related Macular Degeneration

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

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Procedure: Subtenon injection of 40 mg triamcinolone acetonide; Diagnostic test: Visometry; Diagnostic test: Fluorescent angiography; Diagnostic test: Refractometry; Diagnostic test: Slit lamp examination; Diagnostic test: Ophthalmoscopy; Diagnostic test: OKT; Diagnostic test: IOP; Procedure: Intravitreal injection of 4 mg triamcinolone acetonide

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.

This study is planned as a follow-up. Patients with with serous pigment epithelial detachment associated with age-related macular degeneration included in it will receive triamcinolone acetonide in accordance with the approved indications for use indicated in the instructions for the use of drugs in Ukraine.

The treatment proposed in this study is based on the world experience and scientific developments of the Filatov Institute of Eye Diseases and Tissue Therapy of the NAMS of Ukraine ". Therefore, it is expected that the benefit / risk ratio in relation to the participation in this study should not be different from that described in the scientific literature and the benefits outweigh the risk. It is known that the absence of treatment in these diseases leads to an irreparable loss of central vision.

• Study Type: Interventional
• Enrollment (Actual): 63
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ukraine
  • Kyiv, Ukraine
    • CPUkraine
  • Mykolaiv, Ukraine, 54000
    • Mykolaiv Region Ophthalmogical Hospital
  • Odessa, Ukraine, 65061
    • The Filatov Institute of Eye Diseases and Tissue Therapy
  • Please Select
    • Odessa, Please Select, Ukraine, 65061
      • Odessa National Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Triamcinolone Acetonide 40 mg; Arm 1	Procedure: Subtenon injection of 40 mg triamcinolone acetonide; Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination.; Diagnostic test: Visometry; Ophthalmic examination; Diagnostic test: Fluorescent angiography; Ophthalmic examination; Diagnostic test: Refractometry; Ophthalmic examination; Diagnostic test: Slit lamp examination; Ophthalmic examination; Diagnostic test: Ophthalmoscopy; Ophthalmic examination; Diagnostic test: OKT; Ophthalmic examination; Diagnostic test: IOP; Ophthalmic examination
Active Comparator: Triamcinolone Acetonide 4 mg; Arm 2	Diagnostic test: Visometry; Ophthalmic examination; Diagnostic test: Fluorescent angiography; Ophthalmic examination; Diagnostic test: Refractometry; Ophthalmic examination; Diagnostic test: Slit lamp examination; Ophthalmic examination; Diagnostic test: Ophthalmoscopy; Ophthalmic examination; Diagnostic test: OKT; Ophthalmic examination; Diagnostic test: IOP; Ophthalmic examination; Procedure: Intravitreal injection of 4 mg triamcinolone acetonide; Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart	Defined study baseline range of ETDRS equivalent of 20/200 to 20/20) in the study eye; a higher score represents better functioning.	Baseline-Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Flattened Pigment Epithelial Detachment	Number of flattened pigment epithelial detachment	Baseline-Month 12
Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence	A negative number indicates improvement (reduced thickness).	Baseline-Month 12
Average Number of Injections	The number of injections administered	Baseline-Month 12
Intraocular pressure	The difference between intraocular pressure at baseline and at Month 12	Baseline-Month 12

Collaborators and Investigators

• Sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
• Collaborators: Odessa National Medical University; Mykolaiv Region Ophthalmogical Hospital; Central Polyclinic of Internal Affairs of Ukraine

Publications and helpful links

General Publications

• V Pasyechnikova N, A Naumenko V, R Korol A, S Zadorozhnyy O, B Kustrin T, O Nasinnyk I. Serous pigment epithelium detachment associated with age-related macular degeneration: a possible treatment approach. Med Hypothesis Discov Innov Ophthalmol. 2012 Winter;1(4):72-5.

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2018
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 21, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Age-related macular degeneration; triamcinolone acetonide; serous pigment epithelium detachment
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 0118U001612/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No