For Healthcare Professionals

A 24-week Study Evaluating the Effectiveness and Safety of Lucentis® 0.2mg in Retinopathy of Prematurity Participants in China


About the study

This is a 24-week, multicenter, open-label, single-arm, observational, post approval commitment study, which is designed to collect effectiveness, safety and other clinical information of intravitreal ranibizumab 0.2 mg for the treatment of Retinopathy of Prematurity (ROP) participants in a real world clinical setting in mainland China.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Signed informed consent from parent(s) or legal guardian(s), in compliance with local requirements
  2. Male or female preterm infants with a birth weight of less than 1500 g

Bilateral ROP with 1 of the following retinal findings in each eye:

  1. Zone I, stage 1+, 2+, 3 or 3+ disease, or
  2. Zone II, stage 3+ disease, or
  3. A-ROP


Exclusion Criteria:

  1. Have a history of hypersensitivity (either the patient or the mother) to ranibizumab or any component of the ranibizumab formulation or to drugs of similar chemical classes
  2. Have been previously exposed to any intravitreal or systemic anti-VEGF agent (either the patient or the mother during this child's pregnancy)
  3. Have used (either the patient or the mother) other investigational drugs as part of another clinical study (other than vitamins and minerals) within 30 days or within 5 half-lives of the other investigational drug, whichever is longer
  4. Have received any previous surgical or nonsurgical treatment for ROP (e.g., ablative laser therapy or cryotherapy, vitrectomy)
  5. Participants who have contraindications according to locally approved ranibizumab label
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Retinopathy of Prematurity

Participants needed


Est. Completion Date

Dec 30, 2024

Treatment type



Novartis identifier


Study number


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