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Intravitreal tPA and C3F8 for the Treatment of Submacular Haemorrhage as a Complication of Neovascular AMD

NCT01835067 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2020-07-14

No results posted yet for this study

Summary

This study will recruit patients who have recently had a submacular haemorrhage (bleed under the part of the retina responsible for detailed vision), as a complication of wet age-related macular degeneration (wet AMD). Wet AMD is a very common disease where abnormal blood vessels form under the retina and leak, causing a significant reduction in vision.

The study will investigate treatment of the bleed with various combinations of the two drugs: tissue plasminogen activator (tPA) - designed to dissolve the blood clot; and perfluoropropane (C3F8) - designed to shift the blood clot away from the central part of the retina (the macula). tPA is a commonly used 'clot-buster' drug for the treatment of stroke. C3F8 is a gas commonly used in eye surgery. Patients recruited will be divided into four groups: control group that receive none of the above drugs; one group that receives only tPA; one group that receives only C3F8; and one group that receives both.

All patients will receive the current gold standard treatment for wet AMD, ranibizumab (Lucentis®).

The aim of the study is to improve vision in a condition, which left untreated, would cause severe visual loss.

Conditions

  • Exudative Macular Degeneration
  • Retinal Hemorrhage

Interventions

DRUG

Ranibizumab

Single intravitreal injection of 500 micrograms ranibizumab in 0.05mls

DRUG

C3F8 Gas

Single intravitreal injection of 0.3 mls C3F8

DRUG

tPA

Single intravitreal injection of 50 micrograms tPA in 0.05 mls

Sponsors & Collaborators

  • King's College Hospital NHS Trust

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-11-30
Completion
2019-12-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs

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 NCT01835067 on ClinicalTrials.gov