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Monoclonal Antibodies

Brolucizumab vs Laser Therapy for Diabetic Retinopathy (CONDOR Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
PDR diagnosis with no previous PRP treatment in the study eye
Diagnosis of type 1 or 2 Diabetes Mellitus (DM) and HbA1c less than or equal to 12% at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 54 and week 96
Awards & highlights

CONDOR Trial Summary

This trial will compare the vision improvement of two treatments for people with diabetes-related eye problems. One treatment is a special laser, and the other is a drug given as an injection.

Who is the study for?
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.Check my eligibility
What is being tested?
The study compares the effectiveness and safety of a medication called Brolucizumab against traditional laser therapy (PRP) in treating PDR. The main goal is to see if Brolucizumab can match PRP's ability to maintain or improve vision after one year.See study design
What are the potential side effects?
Brolucizumab may cause side effects such as inflammation inside the eye, potential increase in intraocular pressure, blood vessel growth on the iris, pain or redness around the injection site, and possible impact on visual acuity.

CONDOR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have PDR and haven't had PRP treatment in the affected eye.
Select...
I have diabetes and my HbA1c level is 12% or lower.

CONDOR Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 54 and week 96
This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 54 and week 96 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in BCVA
Secondary outcome measures
Area under the curve in change from Baseline in BCVA up to Week 54 and Week 96
Diabetic Retinopathy
Proportion of study eyes developing vision-threatening complications associated with diabetic retinopathy up to Week 54 and Week 96
+4 more

Side effects data

From 2022 Phase 3 trial • 734 Patients • NCT04005352
6%
Conjunctival haemorrhage - Study Eye
6%
Neovascular age-related macular degeneration - Fellow Eye
5%
Visual acuity reduced - Study Eye
5%
Hypertension
5%
Eye pain - Study Eye
4%
Vitreous floaters - Study Eye
3%
Urinary tract infection
3%
Nasopharyngitis
3%
Headache
3%
Vitreous detachment - Study Eye
2%
Atrial fibrillation
2%
Diarrhoea
2%
Fall
2%
Back pain
2%
Osteoarthritis
2%
Dry eye - Fellow Eye
2%
COVID-19
2%
Intra-ocular injection complication - Study Eye
2%
Dry eye - Study Eye
1%
Dizziness
1%
Subretinal fibrosis - Study Eye
1%
Uveitis - Study Eye
1%
Foreign body sensation in eyes - Study Eye
1%
Cataract - Study Eye
1%
Choroidal neovascularisation - Fellow Eye
1%
Conjunctival haemorrhage - Fellow Eye
1%
Vertigo
1%
Pneumonia
1%
Conjunctivitis - Fellow Eye
1%
Cardiac failure congestive
1%
Wrist fracture
1%
Retinal haemorrhage - Study Eye
1%
Femoral neck fracture
1%
Cystitis
1%
Vision blurred - Study Eye
1%
Subretinal fluid - Study Eye
1%
Conjunctivitis - Study Eye
1%
Cough
1%
Constipation
1%
Neovascular age-related macular degeneration - Study Eye
1%
Gamma-glutamyltransferase increased
1%
Vitreous detachment - Fellow Eye
1%
Carpal tunnel syndrome
1%
Eye pain - Fellow Eye
1%
Intraocular pressure increased - Study Eye
1%
Vomiting
1%
Myocardial infarction
1%
Hypercholesterolaemia
1%
Posterior capsule opacification - Study Eye
1%
Cardiac failure
1%
Eye pruritus - Study Eye
1%
Hordeolum - Study Eye
1%
COVID-19 pneumonia
1%
Anxiety
1%
Visual acuity reduced - Fellow Eye
1%
Vaccination complication
1%
Macular oedema - Study Eye
1%
Retinal pigment epithelial tear - Study Eye
1%
Diabetes mellitus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Brolucizumab 6mg
All Patients
Aflibercept 2mg

CONDOR Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Brolucizumab ArmExperimental Treatment1 Intervention
Intra-vitreal injection
Group II: Panretinal photocoagulation laser ArmActive Control1 Intervention
laser
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brolucizumab 6 mg
2018
Completed Phase 3
~890

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,855 Previous Clinical Trials
4,196,659 Total Patients Enrolled
6 Trials studying Diabetic Retinopathy
988 Patients Enrolled for Diabetic Retinopathy

Media Library

Brolucizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04278417 — Phase 3
Diabetic Retinopathy Research Study Groups: Panretinal photocoagulation laser Arm, Brolucizumab Arm
Diabetic Retinopathy Clinical Trial 2023: Brolucizumab Highlights & Side Effects. Trial Name: NCT04278417 — Phase 3
Brolucizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04278417 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to include new participants in this research?

"Yes, this is an ongoing study that is recruiting patients, as per the information on clinicaltrials.gov. The trial was posted on November 19th 2020 and updated on September 28th 2022. They are looking for 706 participants from 3 sites."

Answered by AI

How many total patients will be enrolled in this research project?

"That is correct, the listing on clinicaltrials.gov affirms that this study is currently recruiting patients. This trial was initially posted on November 19th, 2020 and was updated on September 28th, 2020. At present, the research is looking for 706 individuals from 3 different locations."

Answered by AI

Is there a greater risk for patients when taking the 6 mg dose of Brolucizumab?

"Brolucizumab 6 mg was given a safety score of 3 because there is already some efficacy data from Phase 3 trials, and multiple rounds of data support its safety."

Answered by AI

What are the results of other Brolucizumab 6 mg investigations?

"As of now, there are 10 ongoing trials evaluating the efficacy of Brolucizumab 6 mg. 5 of those studies are currently in Phase 3. Although a majority of the Brolucizumab 6 mg trials are concentrated in Porto and Cataluna, there are 360 research centres running these investigations."

Answered by AI

Does this trial explore new territory in the medical field?

"Novartis Pharmaceuticals sponsored the first trial for Brolucizumab 6 mg in 2019. The Phase 3 drug approval followed the first trial in 2019, which involved 263 people. At present, there are 10 active trials for Brolucizumab 6 mg across 146 cities and 29 countries."

Answered by AI

Who else is applying?

What site did they apply to?
Novartis Investigative Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
2020. "Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04278417.
All > Diabetic Retinopathy
~157 spots leftby Apr 2025
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