MAD Trial: Myopia Atropine Dose

Last updated: February 19, 2024
Sponsor: Erasmus Medical Center
Overall Status: Active - Recruiting

Phase

3

Condition

Myopia

Treatment

Atropine Ophthalmic 0.5%

Atropine Ophthalmic 0.05%

Clinical Study ID

NCT05667454
NL78526.078.21
2021-004015-11
MEC-2021-0814
  • Ages 6-11
  • All Genders

Study Summary

The goal of this interventional study is to compare the efficacy of Atropine 0.05% to Atropine 0.5% treatment against progression of axial length in European children with progressive myopia, and to evaluate the safety, adherence, and reasons for nonresponse. Subjects will use Atropine eye drops for a period of 3 years, followed by a 2 year observational period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children aged 6 to ≤ 11 years with bilateral myopia
  • Onset of myopia ≥ 4 years of age
  • History of progression ≥ -0.5D/yr.
  • SER of at least -1.50D and no greater than -6.00D in each eye measured usingcycloplegic auto refraction
  • Intraocular pressure < 21 mm Hg in each eye
  • Distance vision correctable to at least 0.1 Log MAR (logarithm of the minimum angle ofresolution) in each eye

Exclusion

Exclusion Criteria:

  • Allergy to atropine or other excipients of the eye drops
  • History of amblyopia or strabismus
  • History of retinal dystrophy or systemic disorder
  • Abnormal ocular biometry aside from axial length
  • History of glaucoma
  • Chronic use of topical or systemic antimuscarinic/anticholinergic medications in the 21 days prior to screening, and/or anticipated need for chronic use over the durationof the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30days in 1 year).
  • Chronic use (more than 3 days a week) of topical ophthalmological medication (prescribed or over the counter) other than the assigned study medication. The use ofartificial tears is allowed but not in the 1 hour before or after the administrationof the study medication.
  • The anticipated need to use chronic ophthalmic or systemic oral corticosteroids duringthe study. (i.e., < 2 weeks)
  • Prior myopia treatments.
  • Employees of the study center and their family members.

Study Design

Total Participants: 550
Treatment Group(s): 2
Primary Treatment: Atropine Ophthalmic 0.5%
Phase: 3
Study Start date:
December 19, 2022
Estimated Completion Date:
December 01, 2028

Study Description

With the current worldwide myopia boom the frequency of high myopia will also increase, and potentially blinding complications such as myopic macular degeneration, retinal detachment, and glaucoma will occur more often. In the Netherlands high myopia will become the most important cause of low vision and blindness by 2050. As treatment options are limited once the eye is fully grown, prevention of a long axial length at childhood is the only way to counteract this prospect. Pharmacological interventions have shown a high efficacy in stopping eye growth, in particular eye drops with high dose Atropine (0.5%, 1%). Nevertheless, the high frequency of side effects (photophobia, reading problems) of these Atropine concentrations has favoured the use of low dose Atropine. Atropine 0.01% is the most commonly used and lowest dosage; it has shown stability of refractive error, but not of axial length. Recent studies have shown that Atropine 0.05% has low risk of side effects, but a higher efficacy than 0.01%. Many ongoing trials are now comparing various low dose Atropine to placebo, but none are comparing the highest low dose to the lowest high dose Atropine.

Connect with a study center

  • Noordwest Ziekenhuisgroep

    Alkmaar,
    Netherlands

    Site Not Available

  • Flevoziekenhuis

    Almere,
    Netherlands

    Active - Recruiting

  • OLVG, locatie Oost

    Amsterdam,
    Netherlands

    Active - Recruiting

  • Ophthalmologistenpraktijk Delfland

    Delft,
    Netherlands

    Active - Recruiting

  • Reinier de Graaf Gasthuis

    Delft,
    Netherlands

    Active - Recruiting

  • Bergman Clinics - Den Bosch

    Den Bosch,
    Netherlands

    Site Not Available

  • Haaglanden Medisch Centrum

    Den Haag,
    Netherlands

    Site Not Available

  • Haga Ziekenhuis

    Den Haag,
    Netherlands

    Active - Recruiting

  • Oogkliniek Den Haag

    Den Haag,
    Netherlands

    Active - Recruiting

  • Deventer Ziekenhuis

    Deventer,
    Netherlands

    Active - Recruiting

  • Albert Schweitzer ziekenhuis

    Dordrecht,
    Netherlands

    Site Not Available

  • Bergman Clinics - Ede

    Ede,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Site Not Available

  • Admiraal de Ruyter Ziekenhuis

    Goes,
    Netherlands

    Active - Recruiting

  • Tjongerschans Heerenveen

    Heerenveen,
    Netherlands

    Active - Recruiting

  • Oogcentrum Noordholland

    Heerhugowaard,
    Netherlands

    Active - Recruiting

  • Isala - Kampen

    Kampen,
    Netherlands

    Site Not Available

  • Leiden University Medical Center

    Leiden,
    Netherlands

    Active - Recruiting

  • Bergman Clinics - Lelystad

    Lelystad,
    Netherlands

    Active - Recruiting

  • Isala - Meppel

    Meppel,
    Netherlands

    Site Not Available

  • St. Antonius

    Nieuwegein,
    Netherlands

    Active - Recruiting

  • Radboudumc

    Nijmegen,
    Netherlands

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Ziekenhuis Rivierenland Tiel

    Tiel,
    Netherlands

    Active - Recruiting

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg,
    Netherlands

    Active - Recruiting

  • Isala - Zwolle

    Zwolle,
    Netherlands

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.