Aflibercept for Age-Related Macular Degeneration and Diabetic Macular Edema

(ELARA Trial)

Recruiting in Palo Alto (17 mi)

+68 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Regeneron Pharmaceuticals

Must be taking: Anti-VEGF

Disqualifiers: Proliferative diabetic retinopathy, others

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications. The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you have been treated with anti-VEGF medications before joining. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug Aflibercept for treating age-related macular degeneration and diabetic macular edema?

Research shows that Aflibercept (Eylea) significantly improves vision in patients with diabetic macular edema compared to other treatments like laser therapy and other drugs. It also improves vision-related quality of life in patients with age-related macular degeneration when switched from another drug, ranibizumab.

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Is Aflibercept safe for treating eye conditions like age-related macular degeneration and diabetic macular edema?

Aflibercept, also known as Eylea or Zaltrap, has been shown to have a good safety profile in clinical trials for treating eye conditions like age-related macular degeneration and diabetic macular edema. Studies have demonstrated its safety when used as an injection into the eye, with no major safety concerns reported.

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How is the drug Aflibercept unique for treating age-related macular degeneration and diabetic macular edema?

Aflibercept is unique because it is an anti-vascular endothelial growth factor (anti-VEGF) drug that is injected directly into the eye, and it has shown significant improvements in visual acuity compared to other treatments like macular laser photocoagulation and other anti-VEGF drugs such as bevacizumab and ranibizumab, especially in patients with worse initial vision.

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Eligibility Criteria

This trial is for adults with nAMD or DME who have already tried other anti-VEGF treatments. It's not specified who can't join, but typically those with health issues that could interfere with the study or pose extra risks are excluded.

Inclusion Criteria

I am over 50 with nAMD needing treatment for CNV lesions.

I am over 18 and have DME affecting the center of my retina.

I've had 3 or more anti-VEGF injections in the last 5 months.

Exclusion Criteria

My eye swelling is not due to diabetes but another cause.

I have CNV in my eye not caused by nAMD.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive aflibercept 8 mg injections every 4 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests aflibercept 8 mg injections in patients with nAMD and DME to assess safety and effectiveness. Participants will receive injections as often as every four weeks to monitor outcomes.

Group I: Aflibercept 8 mg Experimental Treatment 1 Intervention

Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Aflibercept is already approved in United States, European Union, United States for the following indications:

🇺🇸 Approved in United States as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

🇪🇺 Approved in European Union as Eylea for:

• Neovascular (Wet) Age-Related Macular Degeneration (AMD)
• Macular Edema following Retinal Vein Occlusion (RVO)
• Diabetic Macular Edema (DME)
• Diabetic Retinopathy (DR)

🇺🇸 Approved in United States as Zaltrap for:

• Metastatic Colorectal Cancer

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Win Retina Arcadia, CA

Salehi Retina Institute dba Retina Associates of Southern California Huntington Beach, CA

VRMG, Inc Sacramento, CA

Retina Consultants of Southern Colorado Colorado Springs, CO

More Trial Locations

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals Lead Sponsor

References

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

Intravitreal aflibercept for diabetic macular oedema: Moorfields' real-world 12-month visual acuity and anatomical outcomes. [2022] Label="OBJECTIVES" NlmCategory="OBJECTIVE">To assess structural and functional outcomes of treatment with intravitreal aflibercept (Eylea®) for diabetic macular oedema in treatment-naive patients.

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

One-year real-life results on effect of intravitreal aflibercept in patients with diabetic macular oedema switched from ranibizumab. [2021] To assess visual and optical coherence tomography-derived anatomical outcomes of treatment with intravitreal aflibercept (Eylea®) for diabetic macular oedema in patients switched from intravitreal ranibizumab (Lucentis®).

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

Evaluation of contrast sensitivity and other visual function outcomes in neovascular age-related macular degeneration patients after treatment switch to aflibercept from ranibizumab. [2022] Label="PURPOSE" NlmCategory="OBJECTIVE">This study evaluated visual function and anatomic and vision-related quality-of-life outcomes in recalcitrant neovascular age-related macular degeneration (AMD) subjects switched to aflibercept (Eylea®) from ranibizumab (Lucentis®).

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

Aflibercept: A Review of Its Use in Diabetic Macular Oedema. [2022] Aflibercept (Eylea(®)) is an anti-vascular endothelial growth factor agent indicated for intravitreal use in the treatment of diabetic macular oedema. In patients with diabetic macular oedema, significantly greater improvements from baseline to week 52 in visual acuity were seen with intravitreal aflibercept versus macular laser photocoagulation in the phase III VISTA-DME and VIVID-DME trials, and versus intravitreal bevacizumab or ranibizumab in those with worse visual acuity at baseline (i.e. Early Treatment Diabetic Retinopathy Study letter score of

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

Vision-Related Quality of Life in Patients with Diabetic Macular Edema Treated with Intravitreal Aflibercept: The AQUA Study. [2020] To examine vision-related quality of life in patients with diabetic macular edema (DME) treated with intravitreal aflibercept (EYLEA, Regeneron Pharmaceuticals, Inc, Tarrytown, NY).

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

Intravitreal aflibercept for neovascular age-related macular degeneration. [2022] Neovascular age-related macular degeneration (AMD) is the leading cause of legal blindness in patients over the age of 50 in the western world. Intravitreally administered anti-VEGF drugs have been developed to halt neovascular growth in AMD. Randomized trials have demonstrated the excellent safety profile and significant benefit of anti-VEGF therapy in maintaining vision. Aflibercept (Eylea(®); Regeneron, NY, USA) is a soluble decoy receptor against VEGF that offers greater potency and binding affinity than other anti-VEGF drugs. Having received US FDA approval for neovascular AMD in November 2011, aflibercept given every 8 weeks after a loading dose was 'clinically equivalent' and statistically noninferior to the current FDA-approved therapy ranibizumab (Lucentis(®); Genentech, CA, USA), given every 4 weeks. This article discusses the clinical background of AMD, development of aflibercept, results of the clinical trials and the future role of aflibercept in ocular neovascular diseases.

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

SHORT-TERM SAFETY PROFILE OF INTRAVITREAL ZIV-AFLIBERCEPT. [2022] To evaluate the safety of intravitreal ziv-aflibercept (Zaltrap) in the treatment choroidal neovascularization secondary to age-related macular degeneration.

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

Safety and Efficacy of Ziv-Aflibercept in the Treatment of Refractory Diabetic Macular Edema. [2022] To evaluate the safety and efficacy of ziv-aflibercept (Zaltrap; Sanofi-Aventis, Bridgewater, NJ/Regeneron Pharmaceuticals, Tarrytown, NY) in the treatment of refractory diabetic macular edema (DME).

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

Aflibercept for Diabetic Macular Edema in Eyes Previously Treated With Ranibizumab and/or Bevacizumab May Further Improve Macular Thickness. [2022] To evaluate the short-term anatomic and visual outcomes after aflibercept (Eylea; Regeneron, Tarrytown, NY) in eyes with diabetic macular edema (DME) previously treated with ranibizumab (Lucentis; Genentech, South San Francisco, CA) and/or bevacizumab (Avastin; Genentech, South San Francisco, CA).

10. Romania pubmed.ncbi.nlm.nih.gov

[Preliminary results of treatment with aflibercept]. [2015] The paper presents the first results concerning the Aflibercept (Eylea) treatment, the last antiVEGF approved for treatment of the age related macular degeneration (AMD), neovascular form and for macular edema due to the central retinal vein occlusion. The treatment was applied to patients presenting AMD, ME and other diseases: myopic and idiopatic choroidal neovascularisation, central serous choroidopathy (CSC) or diabetic macular edema (DME). The results were good: improvement of the visual acuity, resolution of the intraretinal fluids and macular edema. Although we did not notice major side-effects, resistance or tachyphylaxis, we noticed some recurrences.

11. Japan pubmed.ncbi.nlm.nih.gov

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial. [2021] To investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME).