A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants 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

2 Aug 2019 → 8 Aug 2025

Decision date (initial)

2023-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

AbbVie Inc.

External identifiers

EU CT number

2022-502380-37-00

EudraCT number

2018-002574-52

ClinicalTrials.gov

NCT03850782

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Safety, Efficacy

To evaluate the duration of IOP-lowering effect of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).

Secondary objectives 1

1. To evaluate the safety of Bimatoprost SR in participants with OAG or OHT who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence).

Conditions and MedDRA coding

Open-Angle Glaucoma

Study design 3 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 15

1. Participant must be at least 18 years of age at the time of signing the informed consent
2. Male or female
3. Written informed consent and authorization for use and release of personal health information are obtained 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]) Participants must not be incarcerated and must be freely willing and able to provide informed consent (eg, adults under legal protection measure [eg, under guardianship/curatorship] or unable to express their consent and select adults under psychiatric care are not eligible). Investigator's discretion should be applied.
4. Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow up period
5. A female participant is eligible to participate if she is not pregnant (ie, has a negative urine pregnancy result at Baseline), not breastfeeding, and at least one of the following conditions applies: a. Not a WOCBP as defined in Appendix 7 of the protocol OR b. A WOCBP who agrees to follow the contraceptive guidance in Appendix 7 of the protocol during the study period
6. Participant is willing to withhold his/her IOP treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk. Note: If participants cannot discontinue their currently prescribed therapy for up to 8 weeks to meet the Washout period for study entry, the investigator may switch the participant's medication to one that requires a shorter washout interval during the washout of the original medication.
7. Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures
8. In the investigator's opinion, participant's IOP is not adequately managed with topical medication for reasons other than medication efficacy (eg, due to intolerance or nonadherence)
9. Diagnosis of either OAG (ie, primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or OHT in the study eye, requiring IOP-lowering treatment
10. In the investigator's opinion, the study eye can be treated adequately with topical prostamide, prostaglandin, or prostaglandin analog (eg, LUMIGAN, Xalatan, Travatan) eye drops as the sole therapy if medication was taken as directed
11. The iridocorneal angle in the study eye must be, in the opinion of the investigator, able to safely receive at least 1 Bimatoprost SR implant using the following criteria: a. Shaffer Grade ≥ 3 on clinical gonioscopy of the inferior angle b. Peripheral anterior chamber depth by Van Herick examination ≥ ½ corneal thickness
12. At the Baseline visit, participant has been appropriately washed out of all IOPlowering medications
13. At the Baseline visit (9:00 AM ± 1 hour), IOP of ≥ 22 and ≤ 34 mm Hg in the study eye
14. Central corneal endothelial cell density by specular microscopy deemed acceptable, in the opinion of the investigator (at Screening, a minimum endothelial cell density of 2000 cells/mm2 in the study eye by automated analysis)
15. At the Baseline visit: BCVA (Snellen equivalent, by manifest refraction) of 20/50 or better in the study eye and 20/100 or better in the fellow eye

Exclusion criteria 13

1. Uncontrolled systemic disease
2. Females who are pregnant, nursing, or planning a pregnancy during the study OR who are WOCBP and will not follow contraceptive guidance
3. Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine)
4. Participants who have a condition or are in a situation which, in the investigator's opinion, may put the participant at significant risk, may confound the study results, or may interfere significantly with the participant's participation in the study;Note: the investigator should consider a participant's overall 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 participant has any symptoms
5. Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit
6. Previous use of commercially available Bimatoprost SR in the study eye; concurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which a Bimatoprost SR implant was received in the study eye. Note: Participants with an eye that has not been previously treated with Bimatoprost SR or participants previously enrolled in Bimatoprost SR studies 192024-091/-092, and -041D who have an eye that was not treated with Bimatoprost SR in that study may be enrolled, provided that the eye that did not receive Bimatoprost SR meets entry criteria for this study
7. Known history of bleeding disorder or prolonged bleeding after surgery (in the opinion of the investigator) Note: Participants receiving pharmacologic blood thinners (eg, aspirin, Coumadin) may be enrolled at the investigator's discretion
8. History of previous laser trabeculoplasty in the study eye
9. History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye
10. The following surgical history in the study eye: a. History or evidence of complicated cataract/lens surgery: eg, surgery resulting in complicated lens placement (such as anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc.) Note: history of uncomplicated cataract surgery is not an exclusion b. History of phakic IOL insertion for refractive error correction
11. Intraocular surgery (including cataract surgery) in the study eye within the 6 months prior to treatment administration (Day 1 Cycle 1 Administration)
12. Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty [DSEK], Descemet's Membrane Endothelial Keratoplasty [DMEK]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye
13. Central corneal thickness of < 480 or > 620 micrometers in the study eye

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Duration of effect of Bimatoprost SR

Secondary endpoints 1

1. Adverse events; visual fields; visual acuity; macroscopic bulbar conjunctival hyperemia; slit-lamp biomicroscopic assessments; dilated ophthalmoscopic assessments (including optic disc assessment); contact ultrasound pachymetry; gonioscopy; specular microscopy

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

Knollstrasse

City

Ludwigshafen Am Rhein

Postcode

67061

Country

Germany

Scientific contact point

Organisation

Abbvie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Contact

Public contact point

Organisation

Abbvie Deutschland GmbH & Co. KG

Contact name

Global Clinical Trials Contact

Third parties 6

Locations

7 EU/EEA countries · 28 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 30 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