New eye injection shows promise for Diabetes-Related vision loss
NCT ID NCT05959304
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
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Novartis Investigative Site
Chennai, Tamil Nadu, 600045, India
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Novartis Investigative Site
Kolkata, West Bengal, 700 073, India
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Novartis Investigative Site
Coimbatore, 641002, India
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Novartis Investigative Site
Kolkata, 700120, India
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Novartis Investigative Site
New Delhi, 110029, India
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