Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

Phase 4

Completed

• Conditions: Diabetic Vitreous Hemorrhage
• Interventions: Procedure: Vitrectomy; Drug: Aflibercept Injection [Eylea]

• Registration Number: NCT04153253
• Lead Sponsor: Al Hadi Hospital

Brief Summary

Prospective study comparing efficacy and safety of intravitreal aflibercept injection and panretinal photocoagulation to early vitrectomy for patients with diabetic vitreous hemorrhage.

Detailed Description

Selected patients were divided into two groups, Group I for whom intravitreal aflibercept injection followed by panretinal photocoagulation was done and group II for whom early vitrectomy was done.

Study Timeline

• Study Start: 2018-03-07
• Primary Completion: 2019-07-22
• Study Completion: 2019-09-29
• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-05
• Study First Posted: 2019-11-06
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Age above 18 years.
• Any sex.
• Type Ι or ΙΙ DM,
• recent diabetic VH which is causing vision impairment, precluding complete PRP and needing treatment.
• BCVA is less than 20/70 (log MAR BCVA 0.6) and better than 20/1000 (log MAR BCVA 1.7).

Exclusion Criteria

• Tractional retinal detachment.
• Previous PRP.
• History of anti VEGF therapy within the past two months.
• Neovascular glaucoma
• Subhyaloid hemorrhage.
• Vitreomacular traction.
• Diabetic macular edema .
• Patients with systemic contraindications for anti VEGF or unstable medical conditions as uncontrolled hypertension (persistently above 180/110 mmhg) or recent thromboembolic event within the past six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II: Early vitrectomy.	Vitrectomy	Early vitrectomy.
Group I	Aflibercept Injection [Eylea]	Intravitreal injection of Aflibercept followed by panretinal photocoagulation.

Primary Outcome Measures

Name	Time	Method
Mean best corrected visual acuity(BCVA) change in both groups.	9 months follow up.	Final BCVA change measured in log MAR compared to initial BCVA.

Secondary Outcome Measures

Name	Time	Method
Rate of recurrent bleeding.	9 months follow up.	Rate of recurrent vitreous hemorrhage in both groups after initial clearance.
Number of additional treatment procedures .	9 months follow up	Additional treatment procedures done in cases of recurrent hemorrhage in both groups.

Trial Locations

Locations (1)

Alhadi Hospital; 🇰🇼 Ḩawallī, Aljabyria, Kuwait