SMZ1 plus ranibizumab vs placebo plus ranibizumab for wet AMD without PCV

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3, randomized, double-blind trial comparing SMZ1 plus ranibizumab to placebo plus ranibizumab in neovascular AMD without PCV. Participants receive SMZ1 or placebo alongside standard ranibizumab therapy, with the goal of improving best-corrected visual acuity at 12 months. Eligibility focuses on adults 50+ with active submacular CNV, no PCV, limited lesion fibrosis, and specific BCVA and lesion size criteria. The study is conducted at Kyung Hee University Hospital in Seoul under SANGMYUNG innovation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 50 years of age or older
* A study eye satisfying all of the following criteria after screening

  ① Active\* submacular choroidal neovascularization due to nAMD confirmed by fluorescein angiography (FAG) and optical coherence tomography (OCT)

  \*Fluorescence leakage confirmed via FAG and intraretinal or subretinal fluid confirmed via OCT

  ② Absence of active polypoidal lesions due to polypoidal choroidal vasculopathy (PCV) confirmed by indocyanine green angiography (ICGA)
* A study eye with fibrosis covering less than 50% of the total lesion area
* A study eye with ETDRS best corrected visual acuity (BCVA) score range of 73-24 at a distance of 4m (equivalent to 20/40-20/320 of Snellen)
* A study eye with a neovascular lesion area of less than 12 optic-disk areas (For an optic nerve head diameter set to 1.8mm, the corresponding optic-disk area is 2.45mm2)
* Provided written informed consent voluntarily after receiving a full explanation of the clinical trial.

Exclusion Criteria:

* History of ocular treatment, systemic therapies, or surgical procedures, such as photodynamic therapy (PDT) and laser photocoagulation, for the treatment of wet nAMD (supplements and vitamins excluded)
* History of anti-VEGF treatment (e.g., ranibizumab, bevacizumab, aflibercept 2mg, or biosimilars) or combination therapy in the study eye for the treatment of wet nAMD
* A study eye with scarring or fibrosis covering more than 50% of the total lesion area
* A study eye with vitreous hemorrhage occurring within 1 month prior to the Screening Visit
* A study eye with intraocular pressure (IOP) ≥ 25mmHg, including glaucoma with IOP ≥ 25mmHg despite medical treatment
* A study eye with a total lesion area (including vessels, scar tissue, and neovascularization) greater than 12 optic-disk areas (\>30.5mm2), as measured by FAG

Where it's running

• Kyung Hee University Hospital
  Seoul, Seoul, South Korea Recruiting

Study contacts

• Study coordinator: Nahyun Kang, Ph.D
• Email: nahyun.kang@sminnovation.com
• Phone: +82 2-3489-6298

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Early imaging changes with faricimab versus biosimilar ranibizumab for diabetic retinal disease

  This trial will see if faricimab or a biosimilar ranibizumab causes different early OCT and OCTA imaging changes in adults with diabetic retinopathy or diabetic macular edema who need anti-VEGF injections.

  Recruiting Osijek University Hospital · Osijek · NCT07520045

• Port Delivery System with ranibizumab refilled every 36 weeks for neovascular (wet) AMD

  This trial tests whether a refillable eye implant that delivers ranibizumab every 36 weeks works and is safe for people with recent neovascular (wet) age-related macular degeneration who responded to prior anti-VEGF injections.

  Recruiting at 63 sites Phase 3 Hoffmann-La Roche · Innsbruck and 63 other locations · NCT06847542

• Switching patients with AMD from ranibizumab or aflibercept to faricimab

  This study is testing if switching people with age-related macular degeneration from their current eye injections to a new treatment called faricimab can improve their vision and reduce the number of injections they need.

  Recruiting Nantes University Hospital · Nantes, Nantes · NCT06271330

• Long-term evaluation of a delivery system for eye treatment in age-related macular degeneration

  This study is testing a new delivery system for eye treatment to see if it is safe and effective for people with a specific type of age-related vision loss.

  Recruiting at 71 sites Phase 3 Hoffmann-La Roche · Phoenix, Arizona and 164 other locations · NCT03683251

• Switching from ranibizumab to aflibercept for eye conditions

  This study is testing if switching patients with certain eye conditions from one medication to another can help improve their vision.

  Recruiting Medical University of Vienna · Vienna · NCT02669953

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.