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

Sponsor
King's College Hospital NHS Trust
Study ID
NCT01835067
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Exudative Macular Degeneration
  • Retinal Hemorrhage

Eligibility Criteria

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

Interventions

  • Ranibizumab — DRUG
    Single intravitreal injection of 500 micrograms ranibizumab in 0.05mls
  • C3F8 Gas — DRUG
    Single intravitreal injection of 0.3 mls C3F8
  • tPA — DRUG
    Single intravitreal injection of 50 micrograms tPA in 0.05 mls

Study Details

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.

Key Dates

First listed
Apr 18, 2013
Start date
Sep 30, 2014
Status verified
Feb 2020
Primary completion
Nov 30, 2019
Completion
Dec 31, 2019

Study Design

Enrollment
55 participants (actual)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Sham Comparator: Control Group (A)
    Ranibizumab only (active control). Participants will receive a 'sham injection' to simulate C3F8 and/or tPA administration.
  • Experimental: C3F8 Only Group (B)
    C3F8 given. Ranibizumab given as standard.
  • Experimental: tPA and C3F8 Group (C)
    Both C3F8 gas and tPA given. Ranibizumab given as standard.
  • Experimental: tPA Only Group (D)
    tPA given. Ranibizumab given as standard.

Primary Outcome Measure

Mean ETDRS visual acuity [ Time Frame: 3 months ]

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