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Preoperative Intravitreal Ranibizumab for Persistent Diabetic Vitreous Haemorrhage:

NCT01030770 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2018-07-27

No results posted yet for this study

Summary

This study will enrol patients with diabetes who have already elected to undergo pars plana vitrectomy (eye surgery) to remove persistent vitreous haemorrhage (a complication of severe diabetic eye disease in which blood fills the inner cavity of the eye, obscuring the vision and preventing treatment to stop the bleeding). Those in the treatment arm will have an intravitreal injection of ranibizumab (Lucentis) at the same dose used for the treatment of neovascular (wet) age-related macular degeneration (a disease that has some features in common with diabetic eye disease).

It is hypothesised that this will promote clearance of the vitreous haemorrhage and that this, in turn, may mean that some patients do not need to proceed to vitrectomy.

Conditions

  • Diabetes Complications

Interventions

DRUG

Ranibizumab

Single intravitreal injection of 500 micrograms of ranibizumab (0.05mls).

DRUG

0.9% Sodium Chloride

Single subconjunctival injection of 0.05mls of 0.9% w/v sodium chloride

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

  • Timothy Jackson, PhD FRCOphth · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2015-12-31
Completion
2016-05-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01030770 on ClinicalTrials.gov