Long-term Safety and Efficacy of Bimatoprost SR for Glaucoma

(Maia Trial)

Recruiting at 268 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Allergan

Must be taking: Bimatoprost SR

Must not be taking: Timolol

Disqualifiers: Pregnancy, Other drug studies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

600 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR or who received commercial DURYSTA (Bimatoprost SR) in the open-label Phase 4 ARGOS study (MED-MA-EYE-0648) and completed (or exited early from) the study.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the drug Bimatoprost SR for glaucoma?

Research shows that bimatoprost, in various forms, effectively lowers intraocular pressure (pressure inside the eye) in patients with glaucoma or ocular hypertension, which is crucial for managing these conditions. ^{1 2 3 4 5}

Is Bimatoprost SR safe for humans?

Bimatoprost, used in eye drops for glaucoma, has been studied for safety in various forms. Some patients experienced eye-related side effects, but it has been generally well-tolerated in long-term use. ^{1 6 7 8 9}

How is the drug Bimatoprost SR different from other glaucoma treatments?

Bimatoprost SR is unique because it is a sustained-release formulation, which means it releases the medication slowly over time, potentially reducing the need for daily eye drops. This can improve convenience and adherence compared to traditional treatments that require frequent application. ^{1 2 5 7 9}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for people who have high blood pressure in the eye, open-angle glaucoma, or ocular hypertension and were part of earlier Bimatoprost SR studies. They must not be pregnant, nursing, planning pregnancy without contraception, or unable to follow study requirements.

Inclusion Criteria

I completed a Phase 3 study for Bimatoprost SR and received the treatment.

I finished or left early from the ARGOS study without safety issues and received DURYSTA.

Exclusion Criteria

You cannot have been given timolol eye drops in your study eye during a previous phase 3 bimatoprost study.

Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.

Concurrent or anticipated enrollment in another investigational drug or device study during the present study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive additional administration of Bimatoprost SR or standard of care based on previous study participation

12 months

Monthly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

Open-label extension

Participants continue to receive Bimatoprost SR to evaluate long-term safety and efficacy

Long-term

Treatment Details

Interventions

• Bimatoprost SR

Trial Overview The long-term safety and effectiveness of Bimatoprost Sustained Release (SR) are being tested on patients with certain eye conditions who previously received this treatment during earlier phases of research.

Participant Groups

Group I: Lead-in study ARGOS Experimental Treatment 2 Interventions

Study eye (Eye that received Bimatoprost SR first in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Treated Fellow eye (Eye that received Bimatoprost SR second in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Untreated Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Untreated fellow eye will receive only standard of care, based on the investigator's judgment.

Group II: Lead-in study 192024-093 Stage 2 Experimental Treatment 2 Interventions

Participants who received 1 Bimatoprost administration due to sustained efficacy: Study eye (Eye that received Bimatoprost SR in the lead-in study): 1 additional administration of Bimatoprost SR may be administered through completion of the Month 12 visit, at least 4 months apart from the lead-in study administration. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

Group III: Lead-in study 192024-093 Stage 1 Experimental Treatment 1 Intervention

Participants who received 1, 2 or 3 administrations and participants in Stage 2 who received 1 Bimatoprost SR administration due to safety concern or received 2 administrations. Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

Group IV: Lead-in study 192024-091 or -092 or -095 Experimental Treatment 1 Intervention

Study eye (Eye that received Bimatoprost SR in the lead-in study): No treatment is administered. Fellow eye (Eye that did not receive Bimatoprost SR in the lead-in study): Fellow eye will receive only standard of care, based on the investigator's judgment.

Who Is Running the Clinical Trial?

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

In a study of 606 patients with primary open-angle glaucoma or ocular hypertension, the fixed combination of bimatoprost 0.03% and timolol 0.5% significantly lowered intraocular pressure (IOP) from a baseline of 20.7 mmHg to 16.1 mmHg after 12 weeks, demonstrating a reduction of 22.2%.

The treatment was well tolerated, with 98.7% of physicians and 96.7% of patients rating its tolerability as excellent or good, and only a few adverse events were reported, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. Feuerhake, C., Buchholz, P., Kimmich, F.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bimatoprost in patients with uncontrolled glaucoma as alternative to filtration surgery. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bimatoprost in patients with elevated intraocular pressure: a 30-day comparison with latanoprost. [2019]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Phase 3, Randomized Study Comparing Intracameral Bimatoprost Implant 15 µg and Selective Laser Trabeculectomy in Patients with Open-Angle Glaucoma or Ocular Hypertension. [2023]

4. New Zealand pubmed.ncbi.nlm.nih.gov

An observational study of bimatoprost 0.01% in patients on prior intraocular pressure-lowering therapy: the Canadian Lumigan(®) RC Early Analysis Review (CLEAR) trial. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy, tolerability and safety of the fixed combination of bimatoprost 0.03% and timolol 0.5% in a broad patient population: multicenter, open-label observational study. [2019]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Iris and periocular adverse reactions to bimatoprost in Japanese patients with glaucoma or ocular hypertension. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Bimatoprost 0.01% vs bimatoprost 0.03%: a 12-month prospective trial of clinical and in vivo confocal microscopy in glaucoma patients. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Two-year double-masked comparison of bimatoprost with timolol in patients with glaucoma or ocular hypertension. [2015]

9. China pubmed.ncbi.nlm.nih.gov

Efficacy and safety of bimatoprost in glaucoma and ocular hypertension in non-responder patients. [2020]