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New eye injection shows promise for Diabetes-Related vision loss

NCT ID NCT05959304

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the safety and effectiveness of brolucizumab, a drug injected into the eye, for treating diabetic macular edema (DME) in 66 Indian patients. DME is a complication of diabetes that can cause vision loss. The study aimed to see how well the drug works in real-world conditions, not just in controlled trials. Results will help doctors understand if brolucizumab is a good option for managing DME.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
brolucizumab (injected into the eye)
What this could lead to
If successful, this could confirm that brolucizumab is a safe and effective option for managing diabetic macular edema in real-world patients.
What could go wrong
This is a small, completed phase IV study with only 66 participants, so results may not apply to all patients. As with any eye injection, there are risks like infection or inflammation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

66 people

The number who actually took part.

Started

Dec 2024

Finished

Nov 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male and female patients ≥ 18 years old with visual impairment due to DME involving the center of the macula. 2. Patients with type 1 or type 2 diabetes mellitus. 3. Patient or legally acceptable representative (LAR) must provide signed informed consent for participation in the study. \- Exclusion Criteria: 1. Concomitant conditions or ocular disorders in the study eye at screening or Baseline which could, in the opinion of the Investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the study period (e.g., cataract, vitreous hemorrhage, retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause). 2. Patient with existing or suspected ocular or periocular infection in the study eye. 3. Patient with an existing intraocular inflammation (IOI) in the study eye. 4. Patient who has undergone intraocular surgery including laser photocoagulation in the study eye within 3 months prior to enrollment in this study. 5. Patient with uncontrolled glaucoma defined as intraocular pressure \> 25 mmHg despite treatment with anti-glaucoma medication, or according to Investigator's judgment. 6. Patient having scar, fibrosis, and atrophy involving the center of the fovea in the study eye. 7. Active proliferative diabetic retinopathy in the study eye as per Investigator. 8. Patient having history of cardiac or cerebral ischemia in last 6 months prior to enrollment in this study. 9. Previous treatment with any anti-VEGF drugs, steroids (dexamethasone intravitreal implant or triamcinolone acetonide) or other investigational drugs in the study eye. 10. Pregnant or nursing (lactating) women at screening, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG pregnancy test.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Novartis Investigative Site

    Ahmedabad, Gujarat, 380052, India

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 010, India

  • Novartis Investigative Site

    Kochi, Kerala, 682 026, India

  • Novartis Investigative Site

    Chennai, Tamil Nadu, 600045, India

  • Novartis Investigative Site

    Kolkata, West Bengal, 700 073, India

  • Novartis Investigative Site

    Coimbatore, 641002, India

  • Novartis Investigative Site

    Kolkata, 700120, India

  • Novartis Investigative Site

    New Delhi, 110029, India

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