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NCT Number: NCT07036510

Safety and Efficacy of TimoD Sustained-Release Implant in Participants With Glaucoma or Ocular Hypertension Undergoing Cataract Surgery

The goal of this clinical trial is to test a new method to deliver an approved medicine called Timolol in the eye of participants with glaucoma or ocular hypertension and requiring cataract surgery.

The study is conducted in two stages. The first stage (Stage 1/Phase 1) is intended to study the safety of 3 different doses of the study medication (called TimoD implant). The second stage (Stage 2/Phase 2) of the study is intended to study in greater detail the efficacy and safety of the 3 doses of the TimoD implant in comparison to a standard approved medication, timolol eye drops for 3 years.

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Key information

Conditions

Glaucoma Cataract Eye Diseases Lens Diseases Ocular Hypertension

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Panama Eye Center

Panama City, Panama

Location status: Recruiting

About this study

Timolol will be administered using an investigational drug product called the TimoD implant.

The implant will be placed in one eye (the study eye) using an instrument called an injector system (an investigational device). The implant procedure will be performed during cataract surgery.

Stage 1: Three dose levels of the TimoD implant (low, intermediate, and high) will be evaluated in three groups of six participants each. Participants will be assigned sequentially to a treatment group and will receive a single implant containing one of the three dose levels. Participants in Stage 1 will be followed for 1 year.

Stage 2: The same three dose levels of the TimoD implant will be evaluated further. In addition, a fourth treatment group receiving an approved control treatment (timolol eye drops) will be included. Six participants will be randomized to each treatment group. Participants in Stage 2 will be followed for 3 years.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Capable of giving signed informed consent.
  • In good general and mental health without ongoing clinically significant abnormalities in medical history.
  • Open-angle glaucoma or ocular hypertension and age-related cataract eligible for intra-capsular IOL placement.
  • Successful, uncomplicated cataract surgery

Exclusion criteria

  • Subjects with a history of hypersensitivity or contraindications to β- blockers.
  • Participants using any systemic or topical drug known to interfere with visual performance, pupil dilation, or iris structure
  • Significant risks caused by washout of ocular hypotensive medications.
  • Clinically significant ocular pathology other than OHT, glaucoma and cataract.

Treatment and study plan

TimoD implant

Drug

Consists of 1 TimoD implant administration in the study eye.

Other names: intraocular implant releasing timolol, investigational drug

Injector system

Device

This is a CE-marked injector intended for intraocular lens (IOL) delivery. In this study, the injector is used as an"intraocular implant injection system" outside of its scope of intended use.

Other names: ACCUJECT™ 2.2.-BL, Investigational device

Timolol eye drops 0.5%

Drug

Timolol eye drops will be self-admnistered twice daily in the study eye approximately 12 hours apart throughout the study

Primary outcomes

  1. Stage 1: Number (%) of participants experiencing adverse events

    Time frame: From Screening (up to Day -41) to end of stage 1 (Month 13)

  2. Stage 1: Number (%) of participants experiencing adverse events of special interest (AESI)

    Time frame: From Screening (up to Day -41) to end of stage 1 (Month 13)

  3. Stage 2: Proportion of responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM IOP)

    Time frame: Month 3

  4. Stage 2: Proportion of time-matched responders defined as an IOP decrease of 20% or more between baseline and Month 3 (8 AM and 10 AM)

    Time frame: Month 3

Study contacts

Contact information is provided by the study sponsor or research team.

EyeD Pharma

CONTACT

[email protected]

+3242299000

Sponsors and collaborators

Lead sponsor

EyeD Pharma

Industry

Registry information

Official study title

Early Feasibility Study to Evaluate the Safety and Efficacy of a New Timolol Sustained-Release Intraocular Implant (TimoD) in Participants With Open-Angle Glaucoma (OAG) or Ocular Hypertension (OHT) Undergoing Cataract Surgery

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 25, 2025
Registry last updated
Jul 30, 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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