An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients with Open Angle Glaucoma or Ocular Hypertension

Overview

Sponsor-declared trial summary

Key facts

Sponsor

AbbVie Deutschland GmbH & Co. KG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

20 Nov 2019 → 10 Apr 2025

Decision date (initial)

2023-12-06

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2023-504601-36-00

EudraCT number

2018-003597-26

ClinicalTrials.gov

NCT03891446

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

- To evaluate the safety of Bimatoprost SR in patients with OAG or OHT
- To evaluate the duration of the IOP-lowering effect of Bimatoprost SR in patients with OAG or OHT

Conditions and MedDRA coding

Open-angle Glaucoma

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Written informed consent and authorization for use and release of personal health information are obtained from patients or their legally authorized representative in accordance with the relevant country and local privacy requirements, where applicable (eg, Written Authorization for Use and Release of Health and Research Study Information [US sites] and written Data Protection consent [EU sites]). Patients must not be incarcerated and must be freely willing and able to provide informed consent (e.g., adults under legal protection measure [e.g., under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care are not eligible). Investigator's discretion should be applied.
2. Patient has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
3. Negative pregnancy test at Screening/Enrollment for females of childbearing potential (as defined in Appendix 6)
4. Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and who were: a.Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter) in the eye that received Bimatoprost SR, OR b. Rescued in the eye that received Bimatoprost SR and require additional safety follow-up for that eye based on the investigator's discretion, OR c.Rescued in the eye that received Bimatoprost SR and require no additional safety follow-up but have clinically significant implant remnants remaining based on the investigator's judgment, OR d.Rescued with topical IOP-lowering medications in the eye that received Bimatoprost SR and are eligible for PRN retreatment in the current study (applicable to patients from lead -in Study 192024 -093 Stage 2 only; see Table 4-1-)
5. Patients who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and who were: a. Not rescued (refers to having received nonstudy IOP-lowering medication[s] or procedure[s] or both, hereafter ) in the eye that received commercial DURYSTA, OR b. Rescued with topical IOP-lowering medications in the eye that received commercial DURYSTA and are eligible for PRN retreatment in the current study (see Table 4-1)

Exclusion criteria 6

1. Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092
2. Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study (see Appendix6)
3. Concurrent or anticipated enrollment in another investigational drug or device study during the present study
4. Any condition which would preclude the patient's ability to comply with study requirements, including completion of the study
5. Patients who have a condition or are in a situation which, in the investigator's opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study. Note: the investigator should consider a patient's o verall health condition, including COVID-19 infection. This should include assessing if the patient is suspected of; quarantined for; or diagnosed with active COVID-19 infection, and whether or not the patient has any symptoms
6. For patients from the ARGOS lead -in study: history of prior incisional glaucoma surgeries in the study eye or treated fellow eye, including (but not limited to) procedures such as: Ahmed Glaucoma Valve, Baerveldt shunt, Ex -Press glaucoma shunt, Molteno shunt, rabeculectomy, etc; and minimally invasive glaucoma surgical procedures such as (but not limited to): CyPass Micro-Stent, Hydrus, iStent, XEN, et

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. AEs, visual field, visual acuity, macroscopic conjunctival hyperemia, slit-lamp biomicroscopic assessments, dilated ophthalmoscopic assessments (including optic disc assessment), contact ultrasound pachymetry, gonioscopy (implant assessment), and specular microscopy.
2. Key endpoint: time from last Bimatoprost SR treatment in the lead-in study to first rescue treatment or first Bimatoprost SR PRN retreatment
3. Additional endpoints: time from SLT treatment in the lead-in study to first rescue treatment in the SLT-treated eye (Phase 3 study comparator) for patients from Study 192024-093 or -095

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

AbbVie Deutschland GmbH & Co. KG

Sponsor organisation

AbbVie Deutschland GmbH & Co. KG

Address

Mainzer Strasse 81

City

Wiesbaden

Postcode

65189

Country

Germany

Scientific contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Public contact point

Organisation

AbbVie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Helpdesk

Third parties 7

Locations

4 EU/EEA countries · 8 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 8 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

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