CompletedPhase 2

Study to Evaluate the Efficacy and Safety of RZ402 in Diabetic Macular Edema (DME)

United States94 participantsStarted 2023-02-06

Plain-language summary

The objective of this trial is to assess the safety, efficacy, and tolerability of RZ402 in patients with Diabetic Macular Edema.

Age range18 Years – 75 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.

✓. Confirmed diabetes mellitus Type 1 or Type 2
✓. Stable glycemic control
✓. Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator.
✓. Spectral Domain Optical Coherence Tomography (SD-OCT) foveal CST at screening measuring ≥320 µm (or corresponding values)
✓. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≤78 letters at screening.
✓. Media clarity, pupillary dilation, and participant cooperation sufficient for adequate clinical evaluations, OCT images and fundus photographs, at screening.
✓. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening.

✕. Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization.
✕. Any history of retinal surgery or other surgical intervention for DME.
✕0. Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period.
✕1. History of trabeculectomy or other filtration surgery (prior laser trabeculoplasty and placement of iStent®1 in conjunction with cataract surgery is permitted if the procedure took place ≥12 weeks prior to Randomization).
✕2. Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation.
✕3. Full thickness macular hole or retinal detachment.
✕4. Panretinal, macular focal, or grid laser photocoagulation within 16 weeks of Randomization or anticipated need for the use of laser photocoagulation during the study period.
✕5. Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg.

Safety Events

Timeframe: 16 weeks

Change in Central Subfield Thickness

Timeframe: 12 weeks

NCT IDNCT05712720

SponsorRezolute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-11

Who can participate

Age range18 Years – 75 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.

✓. Confirmed diabetes mellitus Type 1 or Type 2
✓. Stable glycemic control
✓. Mild to moderate non-proliferative diabetic retinopathy (NPDR) with retinal thickening due to CI-DME as determined by the Investigator.
✓. Spectral Domain Optical Coherence Tomography (SD-OCT) foveal CST at screening measuring ≥320 µm (or corresponding values)
✓. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≤78 letters at screening.
✓. Media clarity, pupillary dilation, and participant cooperation sufficient for adequate clinical evaluations, OCT images and fundus photographs, at screening.
✓. Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening.

✕. Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization.
✕. Any history of retinal surgery or other surgical intervention for DME.
✕0. Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period.
✕1. History of trabeculectomy or other filtration surgery (prior laser trabeculoplasty and placement of iStent®1 in conjunction with cataract surgery is permitted if the procedure took place ≥12 weeks prior to Randomization).
✕2. Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation.
✕3. Full thickness macular hole or retinal detachment.
✕4. Panretinal, macular focal, or grid laser photocoagulation within 16 weeks of Randomization or anticipated need for the use of laser photocoagulation during the study period.
✕5. Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg.