Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Procedure: Subtenon injection of 40 mg triamcinolone acetonide
* Procedure: Intravitreal injection of 4 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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Age-related macular degeneration, serous pigment epithelium detachment, triamcinolone acetonide