Efficacy and Safety of Low-dose Conbercept for Retinopathy of Prematurity Therapy

Inclusion Criteria:

• Preterm infants with less than or equal to 2000 grams of birth weight or less thanor equal to 32 weeks of gestational age

• Bilateral type 1 ROP with one of the following retinal findings in each eye

• Zone I, stage 1+, 2+, 3+/- disease, or

• Zone II, stage 2+, 3+, disease, or

• A-ROP

Exclusion Criteria:

• Preterm infants with stage 4 or 5 ROP in one or both eyes

• Have received any previous surgical or nonsurgical treatment for ROP, includinglaser photocoagulation, anti-VEGF therapy, vitrectomy

• Have been previously exposed to any intravitreal or systemic anti-VEGF agent (eitherthe patient or the mother during this child's pregnancy)

• Have used (either the patient or the mother) other investigational drugs as part ofanother clinical study (other than vitamins and minerals) within 30 days or within 5half-lives of the other investigational drug, whichever is longer

• Have active ocular infection within 5 days before or on the day of firstinvestigational treatment

• Have a history of hypersensitivity (either the patient or the mother) to any of theinvestigational treatments or to drugs of similar chemical classes

• Have any contraindication for intravitreal injection clearly stated in theinstructions

• Have any ocular structural abnormality that may affect efficacy assessments

• Have a history of any other congenital or systemic conditions that are assessed bythe investigator to have a significant risk of severe impact on visual function

• Have any other medical conditions or clinically significant comorbidities orpersonal circumstances that are assessed by the investigator to have a clinicallyrelevant impact on study participation, any of the study procedures, or on efficacyassessments