The randomized clinical trial aims to compare the therapeutic effects between panretinal photocoagulation(PRP) and PRP combined with intravitreal conbercept (IVC) injection in severe nPDR with/without diabetic macular edema patients.
This was a prospective, randomized, two-armed study to assess the efficacy and safety of intravitreal conbercept injection plus PRP versus PRP in the treatment of nPDR patients with/without diabetic macular edema for a period of 1 year. This was an investigator-initiated study performed by department of ophthalmology, Ruijin hospital affiliated with Shanghai Jiaotong University School of Medicine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
40
Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.
The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.
Ruijin Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGChange in best-corrected visual acuity (BCVA)
To assess the effects of two therapies on visual acuity
Time frame: from baseline to month 12
Change in central subfield thickness
optical coherence tomography (OCT) for the assessment of central macular thickness
Time frame: from baseline to month 12
Fundus fluorescein angiography
fluorescein angiography to measure area of fluorescein leakage (FLA)
Time frame: from baseline to month 12
Foveal avascular zone
Optical coherence tomography angiography (OCTA) for measurement of FAZ
Time frame: from baseline to month 12
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