研究目的
To assess the efficacy and safety of ranibizumab with or without panretinal laser photocoagulation (PRP) compared with PRP alone in patients with proliferative diabetic retinopathy (PDR) without diabetic macular oedema.
研究成果
Ranibizumab monotherapy is more effective compared with PRP monotherapy in decreasing NV area over a 12-month period and improving visual outcomes in PDR, even in patients without DME. Long-term follow-up is warranted to investigate patient adherence to anti-VEGF therapy over a longer period and to evaluate the recurrence rates of NV under ranibizumab monotherapy.
研究不足
The study duration was limited to 12 months, and a longer follow-up is required to fully elucidate the durability of ranibizumab monotherapy in PDR. The relatively small number of patients may affect the representativeness of the findings. The decision to retreat was at the investigator’s discretion, potentially introducing subjective bias.
1:Experimental Design and Method Selection:
A 12-month, phase II, multicentre, open-label (but reading centre-blinded), randomized, active-controlled clinical trial comparing ranibizumab monotherapy, PRP monotherapy, and combined ranibizumab/PRP therapy in PDR patients without diabetic macular oedema.
2:Sample Selection and Data Sources:
106 PDR patients without diabetic macular oedema were randomized. Key inclusion criteria included PDR secondary to type 1 or type 2 diabetes, age ≥18 years, best-corrected visual acuity (BCVA) ≥20 ETDRS letters, and HbA1c ≤12%.
3:2%. List of Experimental Equipment and Materials:
3. List of Experimental Equipment and Materials: Ranibizumab
4:5 mg, PRP laser spots (500 μm spot size at the retina), fluorescein angiography (FA), spectral-domain optical coherence tomography (SD-OCT), and wide-field colour fundus photography. Experimental Procedures and Operational Workflow:
Patients received ranibizumab injections or PRP laser spots based on their group assignment. FA and SD-OCT images were captured at screening, Months 3 and
5:Data Analysis Methods:
Change in area of retinal neovascularization (NV) was the primary outcome. Secondary outcomes included BCVA change, complete regression of leakage from NV, and safety.
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