Ranibizumab in Diabetic Vitrectomy. A Prospective, Randomised Controlled Trial of Ranibizumab Pre-treatment in Diabetic Vitrectomy - a Pilot Study

Sponsor
Moorfields Eye Hospital NHS Foundation Trust
Study ID
NCT01306981
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
  • Saline — DRUG
    Subconjunctival injection of 0.05ml saline 0.9% w/v

Study Details

This study will evaluate the effect of ranibizumab on patients undergoing vitrectomy surgery for the complications of diabetic retinopathy. Vitrectomy surgery can be difficult and bleeding after the operation can reduce vision for patients. Our hypothesis is that injection into the eye of ranibizumab one week before surgery will make the surgery easier, reduce complications and improve outcome. In this trial, patients will be randomly allocated to receive either ranibizumab injection or a placebo injection of saline. Neither the patient, their surgeon, nor the study investigators will know which they have received so that a fair comparison can be made.

Key Dates

First listed
Mar 2, 2011
Start date
Mar 30, 2011
Status verified
Sep 2020
Primary completion
Mar 31, 2013
Completion
Mar 12, 2013

Study Design

Enrollment
30 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ranibizumab
  • Placebo Comparator: Saline

Primary Outcome Measure

Best corrected visual acuity [ Time Frame: 12 weeks post-op ]

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