Glaucoma, open-angl… · Phase IV (2023-510041-16-00)

Start 22 Apr 2013 · Status Ongoing, recruitment ended · 1 EU/EEA countries · 1 sites · Protocol GITS

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruitment ended

Participants planned 240

Countries 1

Sites 1

Glaucoma, open-angle and PEX glaucoma

To compare the perimetric rate of progression with two types of initial treatment; mono drop therapy and combo drop therapy + third medication + LTP 360° on patients with newly diagnosed open-angle glaucoma, definied as confirmed vision loss with papill/nerve fibre damage.

Key facts

Sponsor: Region Vaesterbotten
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Phenomena and Processes [G] - Ocular Physiological Phenomena [G14]
Trial duration: 22 Apr 2013 → ongoing
Decision date (initial): 2024-05-16
Transition trial: Yes
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-510041-16-00
EudraCT number: 2013-002895-42

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Secondary objectives 4

To monitor the effect of adherence for rate of progression.
To identify factors at early diagnosis that can effect the rate of progression: Single subject – age, heredity, sex, origin, other diseases, medication, blood pressure. Life style– smoking, BMI, alcohol use, coffee drinking, diet, physical activity Eyes– eye pressure, PEX , refraction, corneal thickness measured with Scheimflug-kamera (Pentacam, Oculus), OCT-techniques (spectral domain optical coherence tomography with enhanced depth imaging).
To measure correlation between structure and function during disease progression by examining the nerve fibre layer and ganglion cell layer with spectral domain optical coherence tomography (SD-OCT). Standard Automated Perimetry (SAP) with Humphrey Field Analyser (Carl Zeiss Meditec).
To measure Quality of Lite for randomised patients at one month visit and after 3, 5, 8 and 10 years; QoL in relation to treatment alternative and rate of progression.

Conditions and MedDRA coding

Glaucoma, open-angle and PEX glaucoma

Version	Level	Code	Term	System organ class
20.0	LLT	10030856	Open-angle glaucoma	10015919
20.0	LLT	10037118	Pseudoexfoliation glaucoma	10015919

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

Newly diagnosed open-angle glaucoma (incl. normal pressure glaucoma) or PEX glaucoma in one or both eyes (both eyes can be included as study eyes if they fulfill the criteria of inclusion/exclusion).
VFI (Visual Field Index)≥65%, applicable for both eyes even if only one eye will be included.
Patient should be previously untreated with intraocular pressure lowering medication.
Age: 40-78 years at time of inclusion.

Exclusion criteria 7

Pregnant or breast feeding women or women in childbearing potential not using acceptable contraceptive method.
Patients with contraindications to the glaucoma medicine to be given.
If there is any obstacle for performing the LTP.
Disease or condition that probably prohibits long-term follow-up.
Intraocular surgery except uncomplicated cataract operation.
Diabetes with proliferative retionopathy or serious non-proliferative retionopathy [(intra-retinal bleedings, pronounced intra-retinal microvasculation, "definite venous beading" macular edema with hard exudates that reach fovea according to International Clinical Diabetic Retionopathy and Macular Edema Disease Severity scales (Wilkinson et al 2003)].
Neurological and other non-glaucoma conditions, except cataract, that can affect the vision.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Rate of progression, the aim of the study is to compare and follow-up the patients on traditional clinical treatment with those receiving more intensive treatment, and measure the rate of progression as long as possible.

Secondary endpoints 2

Quality of life
Compliance and adherence

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 12

Brimonidine

SCP142924 · ATC

Active substance: Brimonidine
Substance synonyms: AGN-190342, UK-1430418, 5-BROMO-6-(2-IMIDAZOLIN-2-YLAMINO)QUINOXALINE
Route of administration: OCULAR USE
Max daily dose: 2 Gtt drop(s)
Max total dose: 7300 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EA05 — BRIMONIDINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Pilocarpine Nitrate

SCP16877661 · ATC

Active substance: Pilocarpine Nitrate
Substance synonyms: HYDROXYPROPYL METHYLCELLULOSE, HYPROMELLOSE (E 464), HPMC, HYDROXYPROPYL METHYL CELLULOSE
Route of administration: OCULAR USE
Max daily dose: 3 Gtt drop(s)
Max total dose: 10950 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EB01 — PILOCARPINE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Brinzolamide

SCP12651926 · ATC

Active substance: Brinzolamide
Substance synonyms: (R)-4-(ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno(3,2-e)-1,2-thiazine-6-sulfonamide 1,1-dioxide, AL-4862
Route of administration: OCULAR USE
Max daily dose: 3 Gtt drop(s)
Max total dose: 10950 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EC04 — BRINZOLAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Timolol Maleate

SCP129633 · ATC

Active substance: Timolol Maleate
Substance synonyms: (S)-Timolol maleate, TIMOLOL HYDROGEN MALEATE, TIMOLOLI MALEAS
Route of administration: OCULAR USE
Max daily dose: 2 Gtt drop(s)
Max total dose: 7300 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01ED01 — TIMOLOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Latanoprost

SCP13242439 · ATC

Active substance: Latanoprost
Route of administration: OCULAR USE
Max daily dose: 1 Gtt drop(s)
Max total dose: 3650 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EE01 — LATANOPROST
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dorzolamide Hydrochloride

SCP12507528 · ATC

Active substance: Dorzolamide Hydrochloride
Route of administration: OCULAR USE
Max daily dose: 3 Gtt drop(s)
Max total dose: 10950 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EC03 — DORZOLAMIDE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Brinzolamide

SCP253570 · ATC

Active substance: Brinzolamide
Substance synonyms: (R)-4-(ethylamino)-3,4-dihydro-2-(3-methoxypropyl)-2H-thieno(3,2-e)-1,2-thiazine-6-sulfonamide 1,1-dioxide, AL-4862
Route of administration: OCULAR USE
Max daily dose: 2 Gtt drop(s)
Max total dose: 7300 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EC54 — BRINZOLAMIDE, COMBINATIONS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Betaxolol

SCP150127 · ATC

Active substance: Betaxolol
Route of administration: OCULAR USE
Max daily dose: 2 Gtt drop(s)
Max total dose: 7300 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01ED02 — BETAXOLOL
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Dorzolamide Hydrochloride

SCP12535123 · ATC

Active substance: Dorzolamide Hydrochloride
Route of administration: OCULAR USE
Max daily dose: 2 Gtt drop(s)
Max total dose: 7300 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01ED51 — TIMOLOL, COMBINATIONS
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Bimatoprost

SCP158236 · ATC

Active substance: Bimatoprost
Route of administration: OCULAR USE
Max daily dose: 1 Gtt drop(s)
Max total dose: 3650 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EE03 — BIMATOPROST
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Timolol

SCP174719 · ATC

Active substance: Timolol
Route of administration: OCULAR USE
Max daily dose: 1 Gtt drop(s)
Max total dose: 3650 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EE04 — TRAVOPROST
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tafluprost

SCP130905 · ATC

Active substance: Tafluprost
Route of administration: OCULAR USE
Max daily dose: 1 Gtt drop(s)
Max total dose: 3650 Gtt drop(s)
Max treatment duration: 120 Month(s)
Authorisation status: Authorised
ATC code: S01EE05 — TAFLUPROST
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Region Vaesterbotten

Sponsor organisation: Region Vaesterbotten
Address: Koksvagen 11, Alidhem Alidhem
City: Umea
Postcode: 907 37
Country: Sweden

Scientific contact point

Organisation: Region Vaesterbotten
Contact name: Gauti Jóhannesson

Public contact point

Organisation: Region Vaesterbotten
Contact name: Gauti Jóhannesson

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Sweden	Ongoing, recruitment ended	240	1
Rest of world	—	0	—

Investigational sites

Sweden

1 site · Ongoing, recruitment ended

Region Vaesterbotten

Ögonkliniken, Koksvagen 11, Alidhem, Umea

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Sweden	2013-04-22		2013-04-22	2017-03-23

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-05-06	Sweden	Acceptable 2024-05-15	2024-05-16

Glaucoma Intensity Treatment Study – Intensive non-invasive glaucoma treatment vs conventional stepwise treatment – a prospective, randomized phase IV study of disease progression in glaucoma

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 4

Conditions and MedDRA coding

Eligibility criteria

Inclusion criteria 4

Exclusion criteria 7

Endpoints

Primary endpoints 1

Secondary endpoints 2

Investigational products

Test 12

Sponsors and contacts

Region Vaesterbotten

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Application history