Brolucizumab vs Laser Therapy for Diabetic Retinopathy

(CONDOR Trial)

Recruiting at 160 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Intravitreal anti-VEGF, Corticosteroids

Disqualifiers: Diabetic macular edema, Uncontrolled glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 96 weeks

689 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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.

What data supports the effectiveness of the drug Brolucizumab and the treatment Panretinal photocoagulation laser for diabetic retinopathy?

Research shows that combining a drug similar to Brolucizumab, called ranibizumab, with panretinal photocoagulation (a laser treatment) can improve outcomes for patients with diabetic retinopathy, such as better visual acuity and reduced eye swelling. ^{1 2 3 4 5}

Is brolucizumab safe for use in humans?

Brolucizumab has been associated with some eye-related side effects, such as inflammation inside the eye and retinal vasculitis (inflammation of the blood vessels in the retina), which can lead to vision loss. These side effects have been observed in treatments for age-related macular degeneration, and safety measures are recommended to manage these risks. ^{6 7 8 9 10}

How does the drug Brolucizumab differ from laser treatment for diabetic retinopathy?

Brolucizumab is a drug that is injected into the eye to reduce abnormal blood vessel growth and swelling, while laser therapy uses light to create small burns on the retina to prevent further vision loss. Brolucizumab offers a different approach by targeting the underlying cause of the condition, potentially providing an alternative for patients who may not respond well to laser treatment. ^{1 11 12 13 14}

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

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

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

My diabetes treatment has been the same for the last 3 months.

You can take clear pictures of the inside of your eye.

Exclusion Criteria

My eye pressure is not higher than 25 mmHg.

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

I have an active infection or inflammation in my eye.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Brolucizumab 6 mg injections or Panretinal Photocoagulation (PRP) laser treatment

96 weeks

Visits every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brolucizumab
• Panretinal photocoagulation laser

Trial Overview 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.

Participant Groups

Group I: Brolucizumab 6 mg Experimental Treatment 1 Intervention

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

Group II: Panretinal photocoagulation laser Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

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

Findings from Research

In a study of 77 patients receiving brolucizumab injections for neovascular age-related macular degeneration, the incidence of ocular adverse effects was found to be 3.5%, with intraocular inflammation occurring in 2.6% of cases.

The findings highlight the potential for serious ocular complications, such as central retinal artery occlusion and retinal detachment, emphasizing the need for thorough discussions about the risks and benefits of brolucizumab treatment with patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular adverse events following intravitreal brolucizumab for neovascular age-related macular degeneration at a single tertiary care center. Nguyen, HV., Li, AS., Silva, AR., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sequence effect in the treatment of proliferative diabetic retinopathy with intravitreal ranibizumab and panretinal photocoagulation. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Patient-Centered Outcomes From a Randomized Clinical Trial. [2022]

3. Brazil pubmed.ncbi.nlm.nih.gov

ETDRS panretinal photocoagulation combined with intravitreal ranibizumab versus PASCAL panretinal photocoagulation with intravitreal ranibizumab versus intravitreal ranibizumab alone for the treatment of proliferative diabetic retinopathy. [2021]

4. Pakistan pubmed.ncbi.nlm.nih.gov

Efficacy of intravitreal bevacizumab combined with pan retinal photocoagulation versus panretinal photocoagulation alone in treatment of proliferative diabetic retinopathy. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Prospective study of peripheral panretinal photocoagulation of areas of nonperfusion in central retinal vein occlusion. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Real-World Frequency and Management of Ocular Adverse Events in Eyes with Neovascular Age-Related Macular Degeneration Treated with Brolucizumab. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

Guidance on brolucizumab management recommendations. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Ocular adverse events following intravitreal brolucizumab for neovascular age-related macular degeneration at a single tertiary care center. [2023]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Inflammatory Complications of Intravitreal Anti-VEGF Injections. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Trends in the Cumulative Post-Marketing Reporting Rates of Retinal Vasculitis and/or Retinal Vascular Occlusion and Associated Vision Loss with Brolucizumab. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Comparison of 577-nm Multispot and Standard Single-Spot Photocoagulation for Diabetic Retinopathy. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

The prognostic value of post-treatment retinopathy after panretinal photocoagulation for proliferative diabetic retinopathy in type 1 diabetes. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Visual loss following panretinal photocoagulation for proliferative diabetic retinopathy. [2022]

14. Austria pubmed.ncbi.nlm.nih.gov

[Recurrence of vasoproliferative activity after photocoagulation. A fluorescence-angiographic study]. [2007]