What side effects are associated with this type of intervention?

The most common treatments for diabetic retinopathy, particularly anti-VEGF agents such as brolucizumab, include side effects like eye pain, vitreous floaters, and increased intraocular pressure. Other potential adverse effects are inflammation inside the eye (endophthalmitis), retinal detachment, and bleeding in the eye. These treatments aim to inhibit abnormal blood vessel growth, but patients should be monitored for these side effects to manage any complications promptly.

What prior FDA approvals exist?

The FDA has approved several anti-VEGF agents for the treatment of Diabetic Retinopathy, which work by inhibiting abnormal blood vessel growth. These include Ranibizumab (Lucentis), Aflibercept (Eylea), and Bevacizumab (Avastin). These drugs have been shown to be effective in reducing vision loss and improving visual acuity in patients with Diabetic Retinopathy by targeting and inhibiting vascular endothelial growth factor (VEGF), thereby reducing abnormal blood vessel formation and leakage.

What other types of research exist?

Promising novel alternatives to Brolucizumab for Diabetic Retinopathy patients include Faricimab, a bispecific antibody targeting both VEGF and Angiopoietin-2, and KSI-301, a novel anti-VEGF biopolymer conjugate. Both have shown positive results in clinical trials and are expected to be available around 2024.

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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

Must not have

Uncontrolled glaucoma (IOP greater than 25 mmHg)

End stage renal disease requiring dialysis or kidney transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up aes are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the week 54 tests (or day 413 for pts who missed the week 54 visit but were ongoing.) the study is still ongoing.

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing if brolucizumab, an eye injection that reduces swelling and stops harmful blood vessel growth, is as effective as laser treatment for patients with severe diabetic eye disease. Brolucizumab has shown excellent results for similar eye conditions.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have PDR and haven't had PRP treatment in the affected eye.

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I have diabetes and my HbA1c level is 12% or lower.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My eye pressure is not higher than 25 mmHg.

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I need dialysis or have had a kidney transplant due to end-stage kidney disease.

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I have an active infection or inflammation in my eye.

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I have no eye conditions that could affect treatment results.

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I have swelling in the retina of my eye due to diabetes.

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My blood pressure is not well-controlled.

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I have been treated with eye injections of corticosteroids.

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I have never received anti-VEGF therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ aes are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the week 54 tests (or day 413 for pts who missed the week 54 visit but were ongoing.) the study is still ongoing.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~aes are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the week 54 tests (or day 413 for pts who missed the week 54 visit but were ongoing.) the study is still ongoing.

This trial's timeline: 3 weeks for screening, Varies for treatment, and aes are reported from first dose of study treatment until the last pt still enrolled at the time of the primary analysis cut-off finished the week 54 tests (or day 413 for pts who missed the week 54 visit but were ongoing.) the study is still ongoing. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54

Secondary study objectives

Area Under the Curve in Change From Baseline in BCVA up to Week 54

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54

Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 18 and Week 54

+7 more

Side effects data

From 2022 Phase 3 trial • 734 Patients • NCT04005352

Conjunctival haemorrhage - Study Eye

Neovascular age-related macular degeneration - Fellow Eye

Visual acuity reduced - Study Eye

Eye pain - Study Eye

Hypertension

Vitreous floaters - Study Eye

Urinary tract infection

Vitreous detachment - Study Eye

Nasopharyngitis

Headache

Back pain

Fall

Diarrhoea

Dry eye - Fellow Eye

Dry eye - Study Eye

Osteoarthritis

Atrial fibrillation

COVID-19

Intra-ocular injection complication - Study Eye

Subretinal fluid - Study Eye

Dizziness

Foreign body sensation in eyes - Study Eye

Subretinal fibrosis - Study Eye

Gamma-glutamyltransferase increased

Vaccination complication

Carpal tunnel syndrome

Intraocular pressure increased - Study Eye

COVID-19 pneumonia

Eye pruritus - Study Eye

Neovascular age-related macular degeneration - Study Eye

Vomiting

Conjunctivitis - Study Eye

Conjunctival haemorrhage - Fellow Eye

Eye pain - Fellow Eye

Visual acuity reduced - Fellow Eye

Pneumonia

Hordeolum - Study Eye

Hypercholesterolaemia

Posterior capsule opacification - Study Eye

Vision blurred - Study Eye

Vertigo

Macular oedema - Study Eye

Constipation

Conjunctivitis - Fellow Eye

Diabetes mellitus

Wrist fracture

Cystitis

Retinal pigment epithelial tear - Study Eye

Uveitis - Study Eye

Retinal haemorrhage - Study Eye

Cardiac failure congestive

Choroidal neovascularisation - Fellow Eye

Femoral neck fracture

Vitreous detachment - Fellow Eye

Myocardial infarction

Cardiac failure

Cataract - Study Eye

Anxiety

Cough

100%

80%

60%

40%

20%

Study treatment Arm

Brolucizumab 6mg

Aflibercept 2mg

All Patients

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Brolucizumab 6 mgExperimental Treatment1 Intervention

Intra-vitreal injection. 3 x q6w loading injections, followed by q12w maintenance through Week 90

Group II: Panretinal photocoagulation laser ArmActive Control1 Intervention

Initial treatment in 1-4 sessions up to Week 12, followed with additional PRP treatment as needed

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Brolucizumab 6 mg

2018

Completed Phase 3

~1580

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Retinopathy include Anti-VEGF agents like Brolucizumab, which inhibit the action of vascular endothelial growth factor (VEGF). VEGF promotes the growth of abnormal blood vessels in the retina, leading to vision loss. By blocking VEGF, these agents reduce the proliferation of these vessels, thereby preserving vision and preventing further complications. Other treatments include laser photocoagulation, which seals leaking blood vessels, and corticosteroids, which reduce inflammation and edema. These treatments are essential for managing the progression of Diabetic Retinopathy and maintaining visual function in patients.