search
Back to results

MAD Trial: Myopia Atropine Dose (MAD)

Primary Purpose

Progressive Myopia

Status
Recruiting
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Atropine Ophthalmic 0.05%
Atropine Ophthalmic 0.5%
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Myopia focused on measuring Myopia, Atropine, Axial length, Child

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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 using cycloplegic 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 of resolution) in each eye 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 duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days 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 of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication. The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks) Prior myopia treatments. Employees of the study center and their family members.

Sites / Locations

  • Noordwest Ziekenhuisgroep
  • Flevoziekenhuis
  • OLVG, locatie Oost
  • Ophthalmologistenpraktijk Delfland
  • Reinier de Graaf Gasthuis
  • Bergman Clinics - Den Bosch
  • Haaglanden Medisch Centrum
  • Deventer Ziekenhuis
  • Albert Schweitzer ziekenhuis
  • Bergman Clinics - Ede
  • Medisch Spectrum Twente
  • Admiraal de Ruyter Ziekenhuis
  • Tjongerschans Heerenveen
  • Oogcentrum Noordholland
  • Isala - Kampen
  • Leiden University Medical Center
  • Bergman Clinics - Lelystad
  • Isala - Meppel
  • St. Antonius
  • Radboudumc
  • Erasmus Medical CenterRecruiting
  • Ziekenhuis Rivierenland Tiel
  • Elisabeth-TweeSteden Ziekenhuis
  • Isala - Zwolle

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Low dose atropine

High dose atropine

Arm Description

Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.

Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.

Outcomes

Primary Outcome Measures

Progression of axial length in mm from baseline to t = 36 months.

Secondary Outcome Measures

Progression of axial length in mm from baseline to t = 60 months.
Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.
Progression of spherical equivalent of refraction in dioptres from baseline to t = 60
Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)
Proportion of subjects who progressed to high myopia (AL 26+ mm)
Change in visual function (BCVA, contrast sensitivity, and glare)
Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)
Proportion of non-adherence
Difference in health related quality of life

Full Information

First Posted
November 21, 2022
Last Updated
January 5, 2023
Sponsor
Erasmus Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development
search

1. Study Identification

Unique Protocol Identification Number
NCT05667454
Brief Title
MAD Trial: Myopia Atropine Dose
Acronym
MAD
Official Title
Investigator Led, Double-masked, Multicenter, Randomized Clinical Trial for the Comparison of Atropine 0.5% Versus Atropine 0.05% Eye Drops for the Prevention of Myopia Progression in Dutch Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 1, 2028 (Anticipated)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center
Collaborators
ZonMw: The Netherlands Organisation for Health Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Myopia
Keywords
Myopia, Atropine, Axial length, Child

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low dose atropine
Arm Type
Active Comparator
Arm Description
Atropine 0.05% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Arm Title
High dose atropine
Arm Type
Active Comparator
Arm Description
Atropine 0.5% sulphate ophthalmic solution should be administered, one drop in each eye, once daily, at bedtime, for 3 years.
Intervention Type
Drug
Intervention Name(s)
Atropine Ophthalmic 0.05%
Intervention Description
Atropine 0.05% sulphate ophthalmic solution
Intervention Type
Drug
Intervention Name(s)
Atropine Ophthalmic 0.5%
Intervention Description
Atropine 0.5% sulphate ophthalmic solution
Primary Outcome Measure Information:
Title
Progression of axial length in mm from baseline to t = 36 months.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Progression of axial length in mm from baseline to t = 60 months.
Time Frame
5 years
Title
Progression of spherical equivalent of refraction in dioptres from baseline to t = 36 months. compared to atropine 0.5% treatment.
Time Frame
3 years
Title
Progression of spherical equivalent of refraction in dioptres from baseline to t = 60
Time Frame
5 years
Title
Proportion of subjects who show ≤ 0.20 mm (good response); 0.2 - 0.3 mm (acceptable response), and > 3 mm (nonresponse)
Time Frame
3 years
Title
Proportion of subjects who progressed to high myopia (AL 26+ mm)
Time Frame
3 years
Title
Change in visual function (BCVA, contrast sensitivity, and glare)
Time Frame
3 years
Title
Frequency and type of treatment-related (serious) adverse events as assessed by CTCAE v5.0 (=safety)
Time Frame
3 years
Title
Proportion of non-adherence
Time Frame
3 years
Title
Difference in health related quality of life
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 using cycloplegic 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 of resolution) in each eye 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 duration of the study (i.e., more than 7 consecutive days in 1 month or more than a total of 30 days 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 of artificial tears is allowed but not in the 1 hour before or after the administration of the study medication. The anticipated need to use chronic ophthalmic or systemic oral corticosteroids during the study. (i.e., < 2 weeks) Prior myopia treatments. Employees of the study center and their family members.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Roelof Polling, Dr.
Phone
+31628449254
Email
j.polling@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Trialbureau Oogheelkunde
Phone
+31107039740
Email
research.oogheelkunde@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
C.C.W. Klaver, Prof. Dr.
Organizational Affiliation
EMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Noordwest Ziekenhuisgroep
City
Alkmaar
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
V. Rooth
Facility Name
Flevoziekenhuis
City
Almere
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
D. Laan
Facility Name
OLVG, locatie Oost
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
van Zijderveld
Facility Name
Ophthalmologistenpraktijk Delfland
City
Delft
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. van der Schans
Facility Name
Reinier de Graaf Gasthuis
City
Delft
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
E. Abma-Bustraan
Facility Name
Bergman Clinics - Den Bosch
City
Den Bosch
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Y. Yong
Facility Name
Haaglanden Medisch Centrum
City
Den Haag
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
M.H.L. Vermeulen-Jongen
Facility Name
Deventer Ziekenhuis
City
Deventer
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N. Bartels
Facility Name
Albert Schweitzer ziekenhuis
City
Dordrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.G.W. Kok
Facility Name
Bergman Clinics - Ede
City
Ede
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. Scholten
Facility Name
Medisch Spectrum Twente
City
Enschede
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
P.J. Lansink
Facility Name
Admiraal de Ruyter Ziekenhuis
City
Goes
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Kieviet- de Geus
Facility Name
Tjongerschans Heerenveen
City
Heerenveen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
J. Fonk
Facility Name
Oogcentrum Noordholland
City
Heerhugowaard
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
R.J. van Geest
Facility Name
Isala - Kampen
City
Kampen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Bos
Facility Name
Leiden University Medical Center
City
Leiden
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
N.E Schalij-Delfos
Facility Name
Bergman Clinics - Lelystad
City
Lelystad
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Boon
Facility Name
Isala - Meppel
City
Meppel
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Bos
Facility Name
St. Antonius
City
Nieuwegein
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L.K. v.d. Jong- van Beek
Facility Name
Radboudumc
City
Nijmegen
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C.C.W. Klaver
Facility Name
Erasmus Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Roelof Polling, Dr.
Phone
+31628449254
Email
j.polling@erasmusmc.nl
Facility Name
Ziekenhuis Rivierenland Tiel
City
Tiel
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
L. Hazeleger-van Zetten
Facility Name
Elisabeth-TweeSteden Ziekenhuis
City
Tilburg
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
C. van den Akker
Facility Name
Isala - Zwolle
City
Zwolle
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
A. Bos

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

MAD Trial: Myopia Atropine Dose

We'll reach out to this number within 24 hrs