CompletedPhase 2

Safety and Efficacy of IBE-814 Intravitreal (IVT) Implant - a Sustained, Low Dose Dexamethasone Therapy

Australia60 participantsStarted 2020-10-30

Plain-language summary

This trial is a phase II, multi-center, single-masked (assessors) dose-ranging study designed to evaluate the comparative safety and preliminary efficacy of two dosage regimens of the IBE-814 IVT Dexamethasone Implant in patients with DMO and RVO.

Who can participate

Age range45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Visual acuity letter score in study eye ≤73 and ≥24 (approximate Snellen equivalent 20/40 to 20/320).
✓. Patient has CST of at least 300 μm (by Cirrus/Spectralis) if measured by Cirrus OCT or 325 μm if measured by Spectralis OCT, with presence of intraretinal and/or subretinal fluid at Screening visit and within 14 days of the baseline treatment visit.
✓. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs.
✓. Study eye has not received any prior intravitreal injections of anti-VEGF or steroids (i.e., treatment naïve).
✓. Birth control pills (The Pill)
✓. Depot or injectable birth control
✓. IUD (Intrauterine Device)
✓. Birth Control Patch

What they're measuring

Best Corrected Visual Acuity

Timeframe: Measurements from baseline to 6 months (24 weeks)

Central Subfield Thickness

Timeframe: Measurements from baseline to 6 months (24 weeks)

Ocular and Non-Ocular Treatment Emergent Adverse Events

Timeframe: Baseline through 18 months

Study Drug-Related Ocular Adverse Events

Timeframe: Baseline through 18 months

Drug-Related Adverse Events

Timeframe: Baseline through 18 months

Post-Injection Complications

Timeframe: Baseline through 18 months

Adverse Events

Timeframe: Baseline through 18 months

Trial details

NCT IDNCT04576689

SponsorRipple Therapeutics Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-25

View on ClinicalTrials.gov More Diabetic Macular Oedema trials

Who can participate

Age range45 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Visual acuity letter score in study eye ≤73 and ≥24 (approximate Snellen equivalent 20/40 to 20/320).
✓. Patient has CST of at least 300 μm (by Cirrus/Spectralis) if measured by Cirrus OCT or 325 μm if measured by Spectralis OCT, with presence of intraretinal and/or subretinal fluid at Screening visit and within 14 days of the baseline treatment visit.
✓. Media clarity, pupillary dilation, and individual cooperation sufficient for adequate OCTs.
✓. Study eye has not received any prior intravitreal injections of anti-VEGF or steroids (i.e., treatment naïve).
✓. Birth control pills (The Pill)
✓. Depot or injectable birth control
✓. IUD (Intrauterine Device)
✓. Birth Control Patch

What they're measuring

Best Corrected Visual Acuity

Timeframe: Measurements from baseline to 6 months (24 weeks)

Central Subfield Thickness

Timeframe: Measurements from baseline to 6 months (24 weeks)

Ocular and Non-Ocular Treatment Emergent Adverse Events

Timeframe: Baseline through 18 months

Study Drug-Related Ocular Adverse Events

Timeframe: Baseline through 18 months

Drug-Related Adverse Events

Timeframe: Baseline through 18 months

Post-Injection Complications

Timeframe: Baseline through 18 months

Adverse Events

Timeframe: Baseline through 18 months