AzTrials
AzTrials

Age-Related Macular DegenerationCOAST_UA_AMDNCT04292756

Triamcinolone Acetonide in Patients With Serous Pigment Epithelial Detachment

A study testing Subtenon injection of 40 mg triamcinolone acetonide, Intravitreal injection of 4 mg triamcinolone acetonide and Visometry in people with Age-Related Macular Degeneration, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 4 sites in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Subtenon injection of 40 mg triamcinolone acetonide, Intravitreal injection of 4 mg triamcinolone acetonide and Visometry
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
4 sitesUkraine
Study dates
27 Mar 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 26Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country.

Ukraine4 sites

  • CPUkraine

    Kyiv

  • Mykolaiv Region Ophthalmogical Hospital

    Mykolaiv, 54000

  • Odessa National Medical University

    Odesa, Please Select, 65061

  • The Filatov Institute of Eye Diseases and Tissue Therapy

    Odesa, 65061

Other trials in Ukraine

About this study

Official title: 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

Read the 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.

Being tested
Subtenon injection of 40 mg triamcinolone acetonide, Intravitreal injection of 4 mg triamcinolone acetonide, Visometry, Fluorescent angiography, Refractometry
Keywords
Age-related macular degeneration, serous pigment epithelium detachment, triamcinolone acetonide
Medical subject headings
Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subtenon injection of 40 mg triamcinolone acetonideProcedure or surgery

    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 acetonideProcedure or surgery

    Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination.

  • VisometryDiagnostic test

    Ophthalmic examination

  • Fluorescent angiographyDiagnostic test

    Ophthalmic examination

  • RefractometryDiagnostic test

    Ophthalmic examination

  • Slit lamp examinationDiagnostic test

    Ophthalmic examination

  • OphthalmoscopyDiagnostic test

    Ophthalmic examination

  • OKTDiagnostic test

    Ophthalmic examination

  • IOPDiagnostic test

    Ophthalmic examination

Study groups in NCT04292756
Study groupRoleWhat they receive
Triamcinolone Acetonide 40 mgActive comparatorArm 1
Receives: 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
Triamcinolone Acetonide 4 mgActive comparatorArm 2
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline-Month 12

Secondary outcomes (4)

  1. Number of Flattened Pigment Epithelial Detachment

    Number of flattened pigment epithelial detachment

    Measured: Baseline-Month 12

  2. Mean Change in Central Retinal Thickness (CRT) as Assessed by Optical Coherence

    A negative number indicates improvement (reduced thickness).

    Measured: Baseline-Month 12

  3. Average Number of Injections

    The number of injections administered

    Measured: Baseline-Month 12

  4. Intraocular pressure

    The difference between intraocular pressure at baseline and at Month 12

    Measured: Baseline-Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2020
  2. Study start27 Mar 2018
  3. Primary completion1 Jul 2020
  4. Study completion31 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
63 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04292756
Sponsor's protocol ID
0118U001612/4
Acronym
COAST_UA_AMD
Status last verified
Aug 2022
First submitted
28 Feb 2020
Last updated
23 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 24600628

Questions about this trial

What is this clinical trial studying?

A study testing Subtenon injection of 40 mg triamcinolone acetonide, Intravitreal injection of 4 mg triamcinolone acetonide and Visometry in people with Age-Related Macular Degeneration, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 4 sites in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Change in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Chart (time frame: Baseline-Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04292756, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.

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