EYE103 for Diabetic Macular Edema

(BRUNELLO Trial)

Recruiting at 106 trial locations

Overseen By Charles Miller, MD PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Recruiting

Sponsor: EyeBiotech Ltd.

Must not be taking: Retinal toxicity drugs

Disqualifiers: Pregnancy, Cataract surgery, others

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of EYE103 in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either EYE103 or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm. Approximately 960 participants will be entered in the study.

Will I have to stop taking my current medications?

The trial requires that you stop using drugs with known retinal toxicity, such as Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone. If you have been treated for diabetic macular edema with certain medications recently, you may also need to stop those before joining the trial.

What data supports the effectiveness of the drug EYE103 for treating Diabetic Macular Edema?

Research shows that ranibizumab, a component of EYE103, is effective in treating diabetic macular edema, as it helps improve vision in patients with this condition. Studies have demonstrated its safety and ability to reduce swelling in the eye, which is crucial for maintaining vision. ^{1 2 3 4 5}

Is EYE103 (Ranibizumab/Lucentis) safe for humans?

Ranibizumab (also known as Lucentis) has been shown to be generally safe in humans for treating conditions like macular edema due to retinal vein occlusion and diabetic macular edema. Common side effects are similar to those seen in treatments for age-related macular degeneration. ^{1 3 6 7 8}

How is the drug EYE103 different from other treatments for diabetic macular edema?

EYE103, which includes ranibizumab (Lucentis), is unique because it offers a new option for patients with diabetic macular edema who have not responded well to other treatments like bevacizumab (Avastin). Ranibizumab is administered through intravitreal injections (injections into the eye), and it has been shown to be effective and safe for managing vision-threatening conditions. ^{1 3 5 9 10}

Research Team

Charles Miller, MD PhD

Principal Investigator

EyeBiotech Ltd.

Eligibility Criteria

This trial is for individuals with diabetic macular edema (DME), a condition causing swelling in the retina due to diabetes. Participants should have this specific eye condition and be willing to receive treatments every 4 weeks for at least one year, with possible adjustments thereafter.

Inclusion Criteria

Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity

I have diabetes with an HbA1c of 12% or less.

I am 18 years old or older.

Exclusion Criteria

I have had specific treatments for diabetic macular edema within certain time frames.

Be pregnant or breastfeeding

I have not had steroid treatment or YAG laser for cataract surgery issues in the last 90 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Year 1

Participants receive intravitreal injections of EYE103 or ranibizumab every 4 weeks

52 weeks

13 visits (in-person)

Treatment Year 2

Participants continue treatment with a personalized treatment interval algorithm

52 weeks

Visits every 4 weeks, adjusted per algorithm

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EYE103 (Monoclonal Antibodies)
• Ranibizumab (Monoclonal Antibodies)

Trial Overview The study compares two doses of a new medication called EYE103 against an established treatment, Ranibizumab, for DME. It's randomized and double-masked, meaning neither participants nor researchers know who gets which treatment. The goal is to determine the effectiveness and safety of EYE103.

Participant Groups

Group I: EYE103 Low Dose Treatment Arm Experimental Treatment 1 Intervention

EYE103 Low Dose Treatment Arm

Group II: EYE103 High Dose Treatment Arm Experimental Treatment 1 Intervention

EYE103 High Dose Treatment Arm

Group III: Ranibizumab Treatment Arm Active Control 1 Intervention

Ranibizumab Treatment Arm

Who Is Running the Clinical Trial?

EyeBiotech Ltd.

Lead Sponsor

Trials

3

Recruited

1,100+

Findings from Research

Intravitreal injections of ranibizumab (Lucentis) have been shown to be an effective and safe treatment option for macular edema caused by retinal vein occlusion, which is a major cause of vision impairment.

Compared to traditional treatments like laser photocoagulation or intravitreal triamcinolone, ranibizumab offers significant improvements in managing this condition, as supported by data from randomized clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Ranibizumab in Macular Edema following Retinal Vein Occlusion. Gallego-Pinazo, R., Dolz-Marco, R., Marín-Lambíes, C., et al.[2021]

Intravitreal injections of ranibizumab significantly improved visual acuity and reduced central retinal thickness in patients with macular edema due to retinal vein occlusion, with average improvements of 9 letters in visual acuity and a decrease of 195 μm in retinal thickness after each injection.

The treatment was found to be safe, with no local or systemic adverse effects reported, but further long-term studies are needed to compare its efficacy against the natural progression of the condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal ranibizumab for macular oedema secondary to retinal vein occlusion: a retrospective study of 34 eyes. Puche, N., Glacet, A., Mimoun, G., et al.[2015]

In two phase 3 clinical trials involving 759 patients, treatment with intravitreal ranibizumab significantly improved patient-reported vision-related function, as measured by the NEI VFQ-25 scores, compared to sham treatment at both 12 and 24 months.

The improvement in vision-related function was particularly notable in better-seeing eyes, with a mean score increase of 10.9 points at 24 months for patients receiving 0.3 mg ranibizumab in the RIDE trial, indicating its efficacy in enhancing quality of life for those with diabetic macular edema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE. Bressler, NM., Varma, R., Suñer, IJ., et al.[2022]

Ranibizumab (Lucentis®) significantly improves visual acuity in patients with macular oedema following retinal vein occlusion, as shown in two phase III trials with monthly injections leading to better outcomes than sham injections at 6 months.

The treatment was generally well tolerated, with adverse events aligning with those seen in other conditions treated with ranibizumab, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ranibizumab: in macular oedema following retinal vein occlusion. Garnock-Jones, KP.[2021]

References

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

Ranibizumab 0.3 mg for Persistent Diabetic Macular Edema After Recent, Frequent, and Chronic Bevacizumab: The ROTATE Trial. [2022]

2. Greece pubmed.ncbi.nlm.nih.gov

Real-world treatment of diabetic macular oedema: a comparison of combined ranibizumab plus macular LASER with macular LASER monotherapy. [2019]

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

Safety and Efficacy of Ranibizumab in Macular Edema following Retinal Vein Occlusion. [2021]

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

Ranibizumab Induces Regression of Diabetic Retinopathy in Most Patients at High Risk of Progression to Proliferative Diabetic Retinopathy. [2019]

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

Comparison of Ranibizumab 0.5 mg Versus 1.0 mg for the Treatment of Patients With Clinically Significant Diabetic Macular Edema: A Randomized, Clinical Trial. [2017]

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

Intravitreal ranibizumab for macular oedema secondary to retinal vein occlusion: a retrospective study of 34 eyes. [2015]

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

Vision-related function after ranibizumab treatment for diabetic macular edema: results from RIDE and RISE. [2022]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Ranibizumab: in macular oedema following retinal vein occlusion. [2021]

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

A Crossover Design for Comparative Efficacy: A 36-Week Randomized Trial of Bevacizumab and Ranibizumab for Diabetic Macular Edema. [2022]

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

Patient-reported outcomes in the RELIGHT clinical trial of ranibizumab in diabetic macular oedema. [2022]