Long-term Safety and Efficacy of Bimatoprost SR for Glaucoma

(MAIA Trial)

Not currently recruiting at 307 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the safety and effectiveness of Bimatoprost SR, a sustained-release eye implant, for individuals with open-angle glaucoma or ocular hypertension. The study targets those who have previously used Bimatoprost SR in earlier trials. Some participants will receive another dose of Bimatoprost SR, while others will receive standard eye care. Ideal participants have taken part in previous Bimatoprost SR studies without safety concerns. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that Bimatoprost SR is likely to be safe for humans?

Studies have shown that Bimatoprost Sustained Release (SR) is generally safe and well-tolerated for treating open-angle glaucoma and high eye pressure. Past research demonstrated that this treatment effectively lowered eye pressure, which is crucial for managing these conditions. Patients in these studies did not report major side effects, suggesting it is likely safe to use.

Additionally, Bimatoprost in other forms, such as the 0.03% eye drop solution, has been used safely for a long time, supporting the safety of the sustained-release version.

This information comes from past studies. Consulting a healthcare professional is always advisable if there are any concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Researchers are excited about Bimatoprost SR for glaucoma because it offers a long-term treatment option through a unique sustained-release delivery system. Unlike traditional eye drops that need daily application, Bimatoprost SR is administered directly into the eye, where it gradually releases the medication over time. This approach not only improves convenience for patients by reducing the frequency of treatment but also potentially enhances adherence and effectiveness, addressing a significant challenge in managing glaucoma with standard eye drops.

What evidence suggests that Bimatoprost SR might be an effective treatment for glaucoma?

Research shows that Bimatoprost Sustained Release (SR) effectively lowers eye pressure in people with open-angle glaucoma or high eye pressure. Studies have found that it safely reduces this pressure, which is crucial for managing these conditions. In this trial, participants may receive additional administrations of Bimatoprost SR, depending on their previous treatment in the lead-in study. Specifically, patients who received the Bimatoprost implant experienced a significant drop in eye pressure, helping to prevent further eye damage. The treatment improves fluid drainage from the eye, reducing pressure buildup. This sustained-release form provides longer-lasting effects with fewer applications, offering a convenient option for many patients. ^{1 2 4 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03891446

NCT03891446 | Long-term Safety and Efficacy Extension ... This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772632025000273

Efficacy of bimatoprost sustained-release implant in ... In summary, the study's findings indicate that the bimatoprost implant effectively and safely treats open-angle glaucoma (OAG) by reducing intraocular pressure ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28528010/

Long-term Safety and Efficacy of a Sustained-Release ... Long-term safety and efficacy of a sustained-release bimatoprost ocular ring. Ophthalmology. 2017 Oct;124(10):1565-1566.

4. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=1698-302-007

Long-term Safety and Efficacy Extension Trial of ... This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension.

5. withpower.com withpower.com/trial/long-term-safety-and-efficacy-of-bimatoprost-sr-for-glaucoma-f59c1

Long-term Safety and Efficacy of Bimatoprost SR for ... This study will evaluate the long-term safety and efficacy of Bimatoprost Sustained Release (SR) in patients with open-angle glaucoma or ocular hypertension ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3116800/

Long-term safety evaluation of bimatoprost ophthalmic ... Bimatoprost 0.03% has a favorable safety and tolerability profile as characterized by six long-term studies.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02250651

NCT02250651 | Efficacy and Safety of Bimatoprost ... This study will evaluate the efficacy and safety of bimatoprost sustained-release (SR) in patients with open-angle glaucoma or ocular hypertension.