NCT04292756

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 27, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 28, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

August 23, 2022

Status Verified

August 1, 2022

Enrollment Period

2.3 years

First QC Date

February 28, 2020

Last Update Submit

August 21, 2022

Conditions

Age-Related Macular Degeneration

Keywords

Age-related macular degenerationserous pigment epithelium detachmenttriamcinolone acetonide

Outcome Measures

Primary Outcomes (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.

    Baseline-Month 12

Secondary Outcomes (4)

  • Number of Flattened Pigment Epithelial Detachment

    Baseline-Month 12

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

    Baseline-Month 12

  • Average Number of Injections

    Baseline-Month 12

  • Intraocular pressure

    Baseline-Month 12

Study Arms (2)

Triamcinolone Acetonide 40 mg

ACTIVE COMPARATOR

Arm 1

Procedure: Subtenon injection of 40 mg triamcinolone acetonideDiagnostic Test: VisometryDiagnostic Test: Fluorescent angiographyDiagnostic Test: RefractometryDiagnostic Test: Slit lamp examinationDiagnostic Test: OphthalmoscopyDiagnostic Test: OKTDiagnostic Test: IOP

Triamcinolone Acetonide 4 mg

ACTIVE COMPARATOR

Arm 2

Procedure: Intravitreal injection of 4 mg triamcinolone acetonideDiagnostic Test: VisometryDiagnostic Test: Fluorescent angiographyDiagnostic Test: RefractometryDiagnostic Test: Slit lamp examinationDiagnostic Test: OphthalmoscopyDiagnostic Test: OKTDiagnostic Test: IOP

Interventions

Subtenon injection of 40 mg triamcinolone acetonidePROCEDURE

Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination.

Triamcinolone Acetonide 40 mg
Intravitreal injection of 4 mg triamcinolone acetonidePROCEDURE

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

Triamcinolone Acetonide 4 mg
VisometryDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
Fluorescent angiographyDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
RefractometryDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
Slit lamp examinationDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
OphthalmoscopyDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
OKTDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg
IOPDIAGNOSTIC_TEST

Ophthalmic examination

Triamcinolone Acetonide 4 mgTriamcinolone Acetonide 40 mg

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Odessa National Medical University

Odesa, Please Select, 65061, Ukraine

Location

CPUkraine

Kyiv, Ukraine

Location

Mykolaiv Region Ophthalmogical Hospital

Mykolaiv, 54000, Ukraine

Location

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

Location

Related 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.

    PMID: 24600628BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Triamcinolone AcetonideFluorescein AngiographySlit Lamp MicroscopyOphthalmoscopy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

TriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAngiographyDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Ophthalmological

Study Officials

  • Andrii MD Korol, PhD

    The Filatov Institute of Eye Diseases and Tissue Therapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Laser Department

Study Record Dates

First Submitted

February 28, 2020

First Posted

March 3, 2020

Study Start

March 27, 2018

Primary Completion

July 1, 2020

Study Completion

December 31, 2020

Last Updated

August 23, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

UA(4)