EC-104 Implant for Diabetic Macular Edema

(BETTIS-1 Trial)

Overseen By Freddie Batalla, MBA

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Eclipse Life Sciences, Inc.

Must be taking: Corticosteroids

Disqualifiers: Glaucoma, Ocular hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

75 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 3 6 7 8}

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. ^{1 2 3 6 7}

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.

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

Treatment Details

Interventions

• Dexamethasone intravitreal implant
• EC-104 high dose
• EC-104 low dose

Trial Overview 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.

Participant Groups

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

Who Is Running the Clinical Trial?

Eclipse Life Sciences, Inc.

Lead Sponsor

Trials

1

Recruited

80+

Findings from Research

The study of 40 eyes from 31 patients demonstrated that repeated intravitreal dexamethasone implants significantly improved best corrected visual acuity in patients with diabetic macular edema (DME) that did not respond to anti-VEGF therapy, with an average improvement of 7.0 letters after the first cycle.

The presence of severe disruption in the outer retinal layers (EZ-ELM) after the first DEX implant was associated with smaller visual acuity gains, suggesting that this disruption could be a predictive factor for treatment outcomes.

NCBI (Pubmed)

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. Hatz, K., Ebneter, A., Tuerksever, C., et al.[2018]

In a three-year study involving 508 patients with diabetic macular edema (DME), the dexamethasone intravitreal implant (DEX 0.7) significantly improved visual acuity and reduced retinal thickness compared to a sham treatment, with 21.5% of DEX 0.7 patients achieving a ≥ 15-letter gain in best-corrected visual acuity.

The safety profile of DEX 0.7 was consistent with previous studies, showing a high incidence of cataract-related adverse events (70.3% in phakic patients), but vision improvements were restored after cataract surgery, indicating that the benefits of DEX 0.7 outweigh the risks in previously treated DME patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone intravitreal implant in previously treated patients with diabetic macular edema: subgroup analysis of the MEAD study. Augustin, AJ., Kuppermann, BD., Lanzetta, P., et al.[2018]

In a study of 75 eyes from 69 patients with diabetic macular edema (DME), the dexamethasone (DEX) implant significantly improved visual acuity and reduced central foveal thickness in both treatment-naive and refractory patients, with effects sustained for up to 6 months.

Treatment-naive patients experienced better visual improvements compared to refractory patients, requiring fewer injections, and no serious ocular complications were reported, although some patients experienced manageable increases in intraocular pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone intravitreal implant for refractory and treatment-naive diabetic macular edema in Taiwanese patients. Wang, JK., Huang, TL., Hsu, YR., et al.[2021]

The study evaluated 113 eyes of 84 patients with diabetic macular edema and found that a dexamethasone intravitreal implant significantly improved visual acuity and reduced central macular thickness at 1 and 3 months after treatment, indicating its efficacy.

Although the improvements in visual acuity and macular thickness declined after 3 months, they remained better than baseline levels at 12 months, and the treatment was associated with minimal ocular complications, suggesting it is a safe option for patients with DME.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravitreal dexamethasone implants for diabetic macular edema. Pareja-Ríos, A., Ruiz-de la Fuente-Rodríguez, P., Bonaque-González, S., et al.[2022]

A single dexamethasone intravitreal implant significantly reduced central macular thickness (CMT) in patients with diabetic macular edema (DME), with a notable decrease observed 2 months after injection.

While visual acuity improved for many patients, with 30% gaining more than 2 logMAR lines, a recurrence of macular edema occurred in 79% of eyes by 4 months, indicating the need for ongoing monitoring and potential additional treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dexamethasone intravitreal implant for the treatment of diabetic macular edema. Bonnin, S., Dupas, B., Sanharawi, ME., et al.[2018]

In a study involving 329 eyes from 282 patients with diabetic macular edema (DME), the intravitreal 0.7-mg dexamethasone implant significantly improved best-corrected visual acuity (BCVA) and reduced central retinal thickness (CRT), indicating its effectiveness in clinical practice.

The treatment was generally safe, with only 7.4% of eyes experiencing a significant increase in intraocular pressure and 4% showing cataract progression, while no cases of serious infections like endophthalmitis were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients with Diabetic Macular Edema: A Real-World Experience. Mello Filho, P., Andrade, G., Maia, A., et al.[2019]

In a study of 101 patients with macular edema (ME) treated with dexamethasone intravitreal implants, significant improvements in visual acuity and central retinal thickness were observed, particularly in patients with uveitis, indicating the efficacy of the treatment for long-standing ME.

While the DEX implants were effective, 20.6% of patients experienced significant increases in intraocular pressure, leading to the initiation of IOP-lowering medications in nearly a third of diabetic ME cases, highlighting the need for monitoring and management of potential side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world assessment of intravitreal dexamethasone implant (0.7 mg) in patients with macular edema: the CHROME study. Lam, WC., Albiani, DA., Yoganathan, P., et al.[2022]

The dexamethasone implant (DEX implant) significantly improves visual acuity and reduces central retinal thickness in patients with diabetic macular edema (DME) over a 6-month period, particularly in pseudophakic eyes and those with subretinal fluid.

Nearly 49% of patients required additional treatments within 6 months, indicating that while the DEX implant is effective, ongoing management may be necessary for optimal results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of a Dexamethasone Implant in Patients with Diabetic Macular Edema at Tertiary Centers in Korea. Moon, BG., Lee, JY., Yu, HG., et al.[2022]

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]

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]

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

Effect of dexamethasone intravitreal implant for refractory and treatment-naive diabetic macular edema in Taiwanese patients. [2021]

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

Intravitreal dexamethasone implants for diabetic macular edema. [2022]

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

Efficacy of dexamethasone intravitreal implant for the treatment of diabetic macular edema. [2018]

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]

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]

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]