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Completed

NCT Number: NCT03891446

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

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.

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Consultorio Oftalmologico Dr. Fabian Lerner /ID# 240247, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.
  • Participants who completed (or exited early from) the open-label Phase 4 ARGOS study with no ongoing safety concerns, and received DURYSTA.

Exclusion criteria

  • Female participants 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.
  • Concurrent or anticipated enrollment in another investigational drug or device study during the present study.
  • Any condition which would preclude the participant's ability to comply with study requirements, including completion of the study.
  • Participants who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092.
  • For patients from the ARGOS lead-in study: history of prior incisional glaucoma surgeries and/or minimally invasive glaucoma surgical procedures in the study eye or treated fellow eye.

Treatment and study plan

Bimatoprost SR

Drug

Intraocular implant

Other names: DURYSTA

Standard of care

Other

Standard of care treatment based on investigator's judgement.

Primary outcomes

  1. Duration of effect of Bimatoprost SR

    Time frame: Approximately 24 months

    Retreatment or rescue administered for IOP lowering, determined by the investigator.

  2. Number of patients experiencing a treatment emergent adverse event

    Time frame: Approximately 24 months

    An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Acronym: MAIA

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2019
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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