Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00591

2 Trial Registration Date

2018-03-09

i Registration Status

Prospective

3 Secondary IDs

KC/KE-16-0252/ER-1

4 Source(s) of Funding

Research Grants Council General Research Fund

5 Primary Sponsor

Research Grants Council General Research Fund

6 Secondary Sponsor

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong

Function

Not Applicable

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Jennifer Tsoi

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
3/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

iii Phone

39435818

iv Email

jennifertsoi@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Prof. Leung Kai Shun Christopher

ii Address

Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong
4/F, Hong Kong Eye Hospital, 147K, Argyle Street, Mongkok, Kowloon, Hong Kong

iii Phone

39435803

iv Email

cksleung@cuhk.edu.hk

v Affiliation

The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Measurement of the Rates of Retinal Nerve Fiber Layer Thinning to Guide Management of Myopic Glaucoma Patients

10 Public Title

Measurement of the Rates of Retinal Nerve Fiber Layer Thinning to Guide Management of Myopic Glaucoma Patients

i Public Title in Chinese 研究名稱

以測量視網膜神經纖維層變薄的速率去指引管理近視青光眼患者

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2017-02-06

iii Full Name of IRB/IEC

Kowloon Central Cluster REC / Kowloon East Cluster REC

Please specify

iv IRB/IEC approval reference number

KC/KE-16-0252/ER-1

14 Medical Condition Being Studied

Glaucoma

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Phase I - Patients will be randomized to receive a prostaglandin analogue (latanoprost) or a fixed-combination of alpha 2 agonist and carbonic anhydrase inhibitor (brinzolamide/brimonidine) after washout of topical IOP-lowering mediation (if any) for 4 weeks.

Phase II - Progressors identified in Phase I will be randomized (using computer generated random numbers) to an additional 20% IOP lowering from the baseline (i.e. mean IOP during follow-up in Phase I) or to continue existing treatment at 24 months. For patients randomized to receive additional IOP-lowering, latanoprost will be provided to those treated with brinzolamide/brimonidine in Phase I; brinzolamide/brimonidine will be provided to those treated with latanoprost in Phase I. If the target IOP cannot be attained with maximally tolerated medications, selective laser trabeculoplasty (SLT) will be performed.

Protocol amendment to include the randomization of latanoprost vs. brinzolamide/brimonidine in Phase I was approved by the Hong Kong Hospital Authority Research Ethnics Committee on 15 Feb 2018.

iii Dosage form of the intervention

Topical medications; selective laser trabeculoplasty

iv Dosage of the intervention

0.005% latanoprost one drop daily; 1% brinzolamide 0.2% brimonidine twice; 360 degrees daily

v Duration of the intervention

Phase I - 24 months; Phase II - 12 months

vi Frequency of the intervention

2-month intervals

16 Comparative Treatments

i Description/ name of comparative treatments

Phase I: latanoprost vs. brinzolamide/brimonidine
Phase II: progressors vs. non-progressors (i.e., eyes progressive RNFL thinning with vs. eyes without progressive RNFL thinning) for continue treatment vs. 20% additional IOP-lowering.

ii Dosage form of the comparative treatments

Topical medications; selective laser trabeculoplasty

iii Dosage of the comparative treatments

0.005% latanoprost one drop daily; 1% brinzolamide 0.2% brimonidine twice daily; SLT - 360 degrees

iv Duration of the comparative treatments

Phase I - 24 months; Phase II - 12 months

v Frequency of the comparative treatments

2-month intervals

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Primary open angle glaucoma patients (POAG) who are: age ≥18 years; best corrected VA ≥20/40; POAG diagnosed within 12 months at the time of recruitment and receiving not more than one IOP-lowering medication.

ii Exclusion Criteria

POAG with IOP>30mmHg; advanced VF loss (VF MD <-18dB in the worse eye) or defects close to fixation (any one of the paracentral points with sensitivity <10dB); pathological myopia (eyes with axial length≥26mm with lacquer cracks and chorioretinal atrophy); ocular or systemic diseases that may cause VF loss or optic disc abnormalities; inability to perform reliable VF; suboptimal quality of SDOCT images; previous intraocular surgery other than uncomplicated cataract extraction; and diabetic retinopathy/maculopathy.

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

Prospective study

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

4

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-04-02

21 Target Sample Size

203

22 Recruitment Status

Suspended

23 Primary Outcome

i The Name of the outcome

Phase I: rate of change of RNFL thickness

ii The metric or method of measurement used

Optical coherence tomography

iii The timepoint(s) of primary interest

24 months

Primary Outcome

i The Name of the outcome

Phase II: proportion of eyes with visual field progression

ii The metric or method of measurement used

Standard automated perimetry

iii The timepoint(s) of primary interest

36 months

24 Secondary Outcome

i The Name of the outcome

Rate of change of visual field mean deviation (MD)

ii The metric or method of measurement used

Standard automated perimetry

iii The timepoint(s) of primary interest

24 and 36 months

Secondary Outcome

i The Name of the outcome

Rate of change of change of RNFL thickness

ii The metric or method of measurement used

Optical coherence tomography

iii The timepoint(s) of primary interest

36 months

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2022-03-24

27 Primary Registry and Trial Identifying Number

ChiCTR1800015147

28 Date of Registration in Primary Registry

2018-03-09

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Trial Detail