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

Korábbi kezelés

• Received more than 3 anti-VEGF injections (including Avastin) and/or received a recent anti-VEGF injection within 8 weeks of Randomization.
• Intraocular surgery (including cataract surgery), within 12 weeks prior to Randomization, or anticipated need for ocular surgery during the study period.
• 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).
• The use of corticosteroids as follows:
  • Topical corticosteroids within 12 weeks prior to Randomization and throughout the remainder of the study.
  • Use of intraocular or sub-Tenon's steroids within 2 years of Randomization in phakic eyes or 9 months of Randomization in pseudophakic eyes, and throughout the remainder of the study.
  • Fellow Eye Exclusion Criteria:
• Intraocular or sub-Tenon's steroid injection within 6 months of Randomization and throughout the remainder or the study.
  • General Exclusion:
• Use of the following medications or substances within the specified timeframes below and throughout the remainder of the study.
  • Within 16 weeks of Randomization: i. Systemic anti-VEGF or pro-VEGF treatments ii. Systemic, approved, or off-label drugs or devices used to treat DME iii. Participated in an investigational drug or device study within 16 weeks or 5 half-lives (whichever is longer) of Randomization, including systemic or ocular studies iv. Initiation of drugs or substances known to improve or worsen macular edema e.g., Latanoprost or phosphodiesterase-5 (PDE-5) inhibitors (e.g., Sildenafil or others in PDE-5 class), but participants may remain on these drugs if they were initiated >16 weeks prior to Randomization.
  • Within 12 weeks of Randomization: i. Use of tobacco- or nicotine- containing products (e.g., cigarettes, cigars, chewing tobacco, snuff, vaping).
  • Within 4 weeks of Randomization: i. Anti-coagulants, except for aspirin ≤325 mg/day and/or clopidogrel ≤75 mg/day (or equivalent drug class) ii. Total daily doses of Metformin >1000 mg iii. Total daily doses of niacin (Vitamin B3) >1.5 g/day iv. Use of systemic steroids at supraphysiologic doses (e.g., prednisone equivalent of 5 mg/day or hydrocortisone equivalent of 20 mg/day).
  • Drugs that may affect the retina or optic nerve such as quinolones, thioridazine, deferoxamine, ethambutol, vigabatrin, and pentosan.
• History of current or prior (within 1 year of Randomization) any significant illness, or any medical history
• History of current or prior (within 1 year of Randomization) abnormal, clinically significant ECG including inadequately controlled hypertension
• Surgical procedure (including open biopsy, surgical resection, wound revision, or any other major surgery involving entry into a body cavity) or significant traumatic injury
• Malignancies within 3 years prior to Randomization
• Donated more than 500 mL of blood or significant blood loss within 60 days before Randomization.

Más betegség

• Any history of retinal surgery or other surgical intervention for DME.
• Autoimmune idiopathic inflammatory eye disease such as anterior uveitis, or participants with history or signs of chronic inflammation.
• History of bariatric surgery or other surgical or medical history
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding.
• Known history of human immune-deficiency virus (HIV), hepatitis C, or hepatitis B infection.

Laborértékek

• Alanine aminotransferase (ALT), or aspartate aminotransferase (AST), or alkaline phosphatase (ALP) ≥2X upper limit of normal (ULN), total bilirubin ≥1.5X ULN, or gamma-glutamyl transferase (GGT) ≥3X ULN as per the central laboratory.
• Estimated glomerular filtration rate (eGFR) at ≤45 mL/min and/or history of persistent micro or macro albuminuria.

Egyéb

• Study Eye Exclusion Criteria:
• Full thickness macular hole or retinal detachment.
• 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.
• Uncontrolled glaucoma, at screening, defined as IOP ≥25 mmHg.

• General Inclusion Criteria:
• Confirmed diabetes mellitus Type 1 or Type 2
• Stable glycemic control
  • Study Eye Inclusion Criteria:
• 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.
  • Fellow Eye Inclusion Criteria:
• Best Corrected Visual Acuity ETDRS letter score at 4 meters of ≥5 letters at screening.