Clinical trial NCT05156021: A Study on the Treatment Strategy of NVG Secondary to PDR
Official title: A Study on the Treatment Strategy of Neovascular Glaucoma Secondary to Proliferative Diabetic Retinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neovascular Glaucoma
Proliferative Diabetic Retinopathy
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: With the increasing incidence of proliferative diabetic retinopathy (PDR), subsequent neovascular glaucoma (NVG) has become one of the main causes of blindness in PDR patients, and the intraocular pressure of PDR patients with NVG is often stubborn. For these patients, not only is the effect of drugs in lowering intraocular pressure poor, but the results of surgery are often unsatisfactory. Because of its poor prognosis, clinical research for better strategy is of great significance in the current situation. At present, for such patients, a combination of effective control of intraocular pressure and treatment of the primary disease is often used. The purpose of this study was to investigate the clinical effects of preoperative with/without intraoperative anti-vascular endothelial growth factor (VEGF) drug therapy combined with pars plana vitrectomy (PPV), pan-retinal photocoagulation (PRP), and pressure-reducing valve implantation in patients with NVG secondary to PDR. Furthermore, the changes of neurotrophic factors in the vitreous humor before and after anti-VEGF treatment will be explored.


Eligibility criteria: Inclusion Criteria:

* male or female patients aged over 18 years diagnosed with type 1 or 2 diabetic mellitus (DM) confirmed by experienced endocrinologists. Active PDR and NVG was clinically evident across these patients. The indications to perform surgery included vitreous hemorrhage or fibrous proliferation in the macular area, together with uncontrolled intraocular pressure.

Exclusion Criteria:

* (i) coexistent ocular disease that may interfere with visual outcome; (ii) previous history of vitrectomy or anti-VEGF pharmacotherapy in either eye; (iii) a macula-involving retinal detachment for \>6 months in the study eye; (iv) severe external ocular infection; (v) usage of anticoagulant or antiplatelet therapy; (vi) preoperative or postoperative poor diabetes control \[serum hemoglobin A1c (HbA1c) \>11.0%\]; (vii) uncontrolled systemic diseases, such as hypertension, cardiac diseases or presenting abnormal coagulation-associated blood diseases.

Primary outcomes:
measure: Changes in Best Corrected Visual Acuity from baseline to 12 months after surgery
timeFrame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
measure: Changes in Intraocular Pressure from baseline to 12 months after surgery
timeFrame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Secondary outcomes:
measure: Changes in Neovascularization Recurrence Rate from baseline to 12 months after surgery
timeFrame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
measure: Changes in Ocular and Systemic Adverse Events from baseline to 12 months after surgery
timeFrame: Follow-up on the first day, first week, 1, 3, 6, 9 and 12 months after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,
Study officials:
affiliation: Ruijin Hospital, Affiliated Shanghai Jiaotong University School of Medicine
name: Xi Shen
role: PRINCIPAL_INVESTIGATOR
References: