Phase 4 N=69 Randomized Double-blind Treatment

Prospective Randomized Controlled Study of Intravitreal Injection of Bevacizumab for Proliferative Diabetic Retinopathy

Proliferative Diabetic Retinopathy · Diabetic Traction Retinal Detachment · Vitreous Hemorrhage

Bottom Line

View on ClinicalTrials.gov: NCT01854593 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2014

Primary outcome: Primary: Reoperation — 1; 7 participants — p=0.033

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Bevacizumab (Drug); Vitrectomy (Procedure); Sham injection (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Nihon University
Primary completion: Aug 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Reoperation	1; 7	0.033 sig
SECONDARY Intra Operative Hemorrhage	0.63; 1.3	0.025 sig
SECONDARY Postoperative Vitreous Hemorrhage.	3; 13	0.006 sig
SECONDARY Vascular Endothelial Growth Factor Concentration in Vitreous	25.0; 1315	<0.0001 sig
SECONDARY Endolaser Photocoagulation	1260; 1335	0.667
SECONDARY Iatrogenic Retinal Tears	5; 5	0.593
SECONDARY Surgical Time	49; 56	0.298
SECONDARY Postoperative Best Corrected Visual Acuity	0.46; 0.43	0.929
SECONDARY Best Corrected Visual Acuity Change	-0.63; -0.73	0.445
SECONDARY Postoperative Neovascular Glaucoma	0; 3	0.131
SECONDARY Elevated Intraocular Pressure	2; 6	0.149
SECONDARY Gas Tamponade	23; 24	0.670
SECONDARY Silicon Oil Tamponade	4; 6	0.378

Summary

We hypothesized that to reduce the adverse effects of intravitreal bevacizumab on ocular tissue and whole body, intravitreal injection of a low concentration of bevacizumab and conducting vitrectomy shortly after the injection is useful. In the present prospective, double-masked, randomized, controlled study, we aimed to verify the usefulness of intravitreal injection of 0.16 mg/0.05 ml bevacizumab one day before conducting vitrectomy for PDR.

Eligibility Criteria

Inclusion Criteria

Clinical diagnosis of Proliferative Diabetic Retinopathy (PDR)
Indicated for vitrectomy

Exclusion Criteria

History of intraocular surgery, intravitreal injection of drugs or sub-Tenon injection of steroids or retinal photocoagulation within 6 months

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Data sourced from ClinicalTrials.gov (NCT01854593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.