Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment

Age-Related Macular Degeneration Clinical Trial

— COAST_UA_AMD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292756
• Other study ID #: 0118U001612/4
• Status: Completed
• Phase: N/A
• Start date: March 27, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: August 2022
• Source: The Filatov Institute of Eye Diseases and Tissue Therapy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: December 31, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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.

• Ma?ular 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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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.
• 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.

Diagnostic Test:
• Visometry
Ophthalmic examination
• Fluorescent angiography
Ophthalmic examination
• Refractometry
Ophthalmic examination
• Slit lamp examination
Ophthalmic examination
• Ophthalmoscopy
Ophthalmic examination
• OKT
Ophthalmic examination
• IOP
Ophthalmic examination

Locations

Country	Name	City	State
Ukraine	CPUkraine	Kyiv
Ukraine	Mykolaiv Region Ophthalmogical Hospital	Mykolaiv
Ukraine	Odessa National Medical University	Odessa	Please Select
Ukraine	The Filatov Institute of Eye Diseases and Tissue Therapy	Odessa

Sponsors (4)

Lead Sponsor	Collaborator
The Filatov Institute of Eye Diseases and Tissue Therapy	Central Polyclinic of Internal Affairs of Ukraine, Mykolaiv Region Ophthalmogical Hospital, Odessa National Medical University

Country where clinical trial is conducted

Ukraine, 

References & Publications (1)

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. — View Citation

Outcome

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