Comparison of clinical outcomes of conbercept versus ranibizumab treatment for retinopathy of prematurity: a multicentral prospective randomised controlled trial

Abstract

Purpose: To compare the recurrence rate and surgical complications of retinopathy of prematurity (ROP) between patients treated with intravitreal injection of conbercept (IVC) and intravitreal injection of ranibizumab (IVR) within 6 months.

Methods: A multicentral prospective, randomised controlled trial was applied from May 2017 to February 2019 for the infants diagnosed as aggressive posterior-ROP, zone I or posterior zone II treatment-requiring ROP by binocular indirect ophthalmoscope and RetCam3. These infants were assigned to randomly receive either intravitreal injection of 0.25 mg conbercept or 0.25 mg ranibizumab. The recurrence rate, fundus fluorescence angiography (FFA) and surgical complications were examined during the follow-up period of 6 months. Recurrent eyes were retreated by laser or another intravitreal injection within the 72 hours.

Results: A total of 30 infant patients (60 eyes) underwent IVC and 30 patients (60 eyes) underwent IVR. A total of 10 eyes (16.67%) in the IVC group and 14 eyes (23.34%) in the IVR group developed recurrence. There was no significant statistical difference in the recurrence rate between the two groups (χ²=0.83, p=0.36). The postmenstrual age (PMA) at first injection was (34.60±3.47) weeks in IVC and (35.14±1.76) in IVR group. In recurrent cases, the mean PMA at second treatment were (43.31±3.85) and (43.43±3.89) weeks in the IVC and IVR group, respectively. The period between two treatments was (8.71±6.62) for the IVC and (8.29±2.56) weeks for the IVR group. All these results showed no significant statistical difference between these two groups. The fluorescein leakage were observed in the eyes of recurrent infants by FFA. There were no other complications in the two groups except for complicated cataract in three eyes.

Conclusion: Both IVC and IVR are effective therapies for the treatment of ROP. Conbercept is a new option for treating ROP.

Keywords: drugs; retina; treatment other.

Figure 1

Fundus images of no recurrence cases. (A–D) fundus images in the IVC group. (E–H) fundus images in the IVR group. (A, E) images before IVI shows plus disease and ridge. (B, F) regression of plus disease and ridge was observed at 1 week after treatment. (C, G) one month after treatment. (D, H) six months after treatment. No recurrence occurred during the 6 months follow-up. IVC, intravitreal injection of conbercept; IVI, intravitreal injection; IVR, intravitreal injection of ranibizumab.

Figure 2

Fundus images of recurrence cases. (A–E) fundus images in the IVC group. (F–J) fundus images in the IVR group. (A, F) Images before IVI shows plus disease and ridge. (B, G) Regression of plus disease and ridge was observed at 1 week after treatment. (C, H) aggravated plus disease and ridge was observed during follow-up. (D, I) FFA shows the retinal neovascularisation and fluorescence. (E, J) six months after IVI. No new recurrence was observed after secondary treatment. FFA, fundus fluorescence angiography; IVC, intravitreal injection of conbercept; IVR, intravitreal injection of ranibizumab.