EC-104 Implant for Diabetic Macular Edema

(BETTIS-1 Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Eclipse Life Sciences, Inc.

Must be taking: Corticosteroids

Disqualifiers: Glaucoma, Ocular hypertension, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide \[FA\] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the EC-104 Implant for Diabetic Macular Edema?

Research shows that the dexamethasone intravitreal implant, a component of the EC-104 treatment, has been effective in improving vision and eye health in patients with diabetic macular edema, even when other treatments have not worked.

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Is the EC-104 Implant (Dexamethasone intravitreal implant) safe for humans?

The Dexamethasone intravitreal implant has been studied for safety in patients with diabetic macular edema, and these studies generally support its safety in humans.

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How is the EC-104 implant for diabetic macular edema different from other treatments?

The EC-104 implant for diabetic macular edema is unique because it involves a new formulation with high and low doses, potentially offering different dosing options compared to the standard dexamethasone intravitreal implant, which is already used for this condition. This could provide more tailored treatment options for patients based on their specific needs.

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Eligibility Criteria

This trial is for people with diabetic macular edema who didn't get better after anti-VEGF therapy and can handle corticosteroids without a big increase in eye pressure. It's not for those who haven't had these treatments or have other eye problems that could interfere.

Inclusion Criteria

Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20/40 or worse) and ≥ 20 letters (Snellen equivalent 20/400) in at least 1 eye

Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations

I have diabetes and had diabetic eye disease for ≤ years before my first screening.

Exclusion Criteria

I have or had glaucoma or high eye pressure needing treatment.

I have had high eye pressure from steroids over 25 mm Hg.

I have active eye disease due to diabetes with new blood vessels or bleeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either EC-104 high-dose, EC-104 low-dose, or Ozurdex® intravitreal implants

24 weeks

Regular visits for implant administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The study tests two doses of EC-104 against a known treatment, Ozurdex, to see which is safer and works better for diabetic retinopathy with swelling in the center of the retina. Participants are randomly assigned to one of the treatments without knowing which one they receive.

Group I: EC-104 low dose Experimental Treatment 1 Intervention

Intravitreal implant of fluocinolone acetonide

Group II: EC-104 high dose Experimental Treatment 1 Intervention

Intravitreal implant of fluocinolone acetonide

Group III: Dexamethasone intravitreal implant Active Control 1 Intervention

Marketed product

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Retina Associates of Florida, LLC Tampa, FL

Who Is Running the Clinical Trial?

Eclipse Life Sciences, Inc. Lead Sponsor

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Repeated Dexamethasone Intravitreal Implant for the Treatment of Diabetic Macular Oedema Unresponsive to Anti-VEGF Therapy: Outcome and Predictive SD-OCT Features. [2018] To investigate dexamethasone intravitreal implant 0.7 mg (DEX implant) for the treatment of diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) therapy and evaluate predictive factors.

2. England pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. [2018] Dexamethasone intravitreal implant 0.7 mg (DEX 0.7) was approved for treatment of diabetic macular edema (DME) after demonstration of its efficacy and safety in the MEAD registration trials. We performed subgroup analysis of MEAD study results to evaluate the efficacy and safety of DEX 0.7 treatment in patients with previously treated DME.

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone intravitreal implant for refractory and treatment-naive diabetic macular edema in Taiwanese patients. [2021] Dexamethasone (DEX) implant has been shown to improve visual and anatomic function in patients with diabetic macular edema (DME). The purpose of this study was to investigate the efficacy and safety of DEX implant between refractory and naive eyes with DME.

4. China pubmed.ncbi.nlm.nih.gov

Intravitreal dexamethasone implants for diabetic macular edema. [2022] To evaluate the safety and efficacy of a dexamethasone (DEX) intravitreal implant for diabetic macular edema (DME).

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

Efficacy of dexamethasone intravitreal implant for the treatment of diabetic macular edema. [2018] To assess the efficacy of a single dexamethasone intravitreal implant (Dex-I) injection for the treatment of diabetic macular edema (DME).

6. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: A Real-World Experience. [2019] There are few real-life studies on the intravitreal 0.7-mg dexamethasone implant for the treatment of diabetic macular edema (DME) conducted in Latin America. We aimed to assess the effectiveness and safety of this implant in clinical practice.

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

Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. [2022] The purpose of this study was to evaluate the real-world use, efficacy, and safety of one or more dexamethasone intravitreal implant(s) 0.7 mg (DEX implant) in patients with macular edema (ME).

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

Efficacy and Safety of a Dexamethasone Implant in Patients with Diabetic Macular Edema at Tertiary Centers in Korea. [2022] Purpose. To evaluate the real-world efficacy and safety of the dexamethasone implant (DEX implant) in patients with diabetic macular edema (DME). Methods. Retrospective, multicenter, and noncomparative study of DME patients who were treated with at least one DEX implant. A total of 186 eyes from 165 patients were included. Best-corrected visual acuity (BCVA), central retinal thickness (CRT), complications, and number of retreatments were collected. Data at baseline and monthly for 6 months were analyzed. Results. The average baseline BCVA and CRT were 0.60 LogMAR and 491.6 μm, respectively. The mean BCVA improved until 3 months and then decreased up to 6 months of follow-up (0.53, 0.49, and 0.55 LogMAR at 1, 3, and 6 months; p = 0.001,