Brolucizumab vs Laser Therapy for Diabetic Retinopathy
(CONDOR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two treatments for people with proliferative diabetic retinopathy (PDR), a serious eye condition that can lead to vision loss in those with diabetes. The goal is to determine if brolucizumab, a medication given by injection, is as effective as the standard laser treatment (panretinal photocoagulation laser) in improving vision. Participants should have type 1 or 2 diabetes, a stable diabetes treatment plan for at least three months, and a PDR diagnosis without previous laser treatment in the study eye. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, your diabetes treatment must be stable for at least 3 months, and you cannot have had certain eye treatments recently.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that brolucizumab is generally safe for people with diabetes. In one study, most participants experienced few side effects, though some groups reported more common side effects. Another study found that about 3.4% of eyes treated with brolucizumab developed issues such as eye inflammation or vision problems. Despite these risks, many individuals tolerate the treatment well, and it is already approved for other eye conditions, indicating a known safety record. It is important to consult a healthcare provider about potential risks before joining a trial.12345
Why do researchers think this study treatment might be promising?
Brolucizumab is unique because it offers a targeted approach for diabetic retinopathy by inhibiting a protein called VEGF, which plays a key role in abnormal blood vessel growth and leakage in the retina. Unlike the standard of care, which often involves laser therapy to physically seal off leaking blood vessels, Brolucizumab works at the molecular level to prevent these issues from developing in the first place. Researchers are excited because this method could not only reduce the number of treatments needed but also improve vision outcomes for patients by directly addressing the underlying cause of the condition.
What evidence suggests that this trial's treatments could be effective for proliferative diabetic retinopathy?
This trial will compare Brolucizumab with Panretinal photocoagulation laser therapy for diabetic retinopathy. Studies have shown that Brolucizumab can significantly improve vision clarity in patients with diabetic eye problems. Research indicates that it reduces fluid in the retina, crucial for eye health, and proves more effective than some treatments, like aflibercept, in keeping eyes dry. Brolucizumab significantly decreases the thickness of the central retina, often linked to better vision. While commonly used for diabetic macular edema (swelling in the eye), its ability to reduce eye fluid could also benefit those with proliferative diabetic retinopathy. Overall, available evidence supports its potential effectiveness in maintaining or improving vision in patients with diabetic eye conditions.45678
Who Is on the Research Team?
Novartis Pharmaceuticals
Principal Investigator
Novartis Pharmaceuticals
Are You a Good Fit for This Trial?
This trial is for individuals with type 1 or 2 diabetes, an HbA1c of ≤12%, and diagnosed proliferative diabetic retinopathy (PDR) without prior laser treatment in the affected eye. Participants must have stable diabetes management for at least three months and be able to undergo retinal imaging.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Brolucizumab 6 mg injections or Panretinal Photocoagulation (PRP) laser treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brolucizumab
- Panretinal photocoagulation laser
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novartis Pharmaceuticals
Lead Sponsor
Dr. Vas Narasimhan
Novartis Pharmaceuticals
Chief Executive Officer since 2018
MD from Harvard Medical School
Dr. Shreeram Aradhye
Novartis Pharmaceuticals
Chief Medical Officer since 2021
MD