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Intravitreal Aflibercept Injection or Early Vitrectomy for Diabetic Vitreous Hemorrhage

A

Al Hadi Hospital

Status and phase

Completed
Phase 4

Conditions

Diabetic Vitreous Hemorrhage

Treatments

Drug: Aflibercept Injection [Eylea]
Procedure: Vitrectomy

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Group I
Active Comparator group
Description:
Intravitreal injection of Aflibercept followed by panretinal photocoagulation.
Treatment:
Drug: Aflibercept Injection [Eylea]
Group II: Early vitrectomy.
Active Comparator group
Description:
Early vitrectomy.
Treatment:
Procedure: Vitrectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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