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

• Status: Completed
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King's College Hospital NHS Trust
• Treatments: Plasminogen; Ranibizumab; Tissue Plasminogen Activator

Criteria

Inclusion criteria:

• Adults of either sex aged 50 years and older;

• SMH associated with treatment-naive or previously treated wet AMD, including retinal angiomatous proliferation (RAP) and idiopathic polypoidal choroidal vasculopathy (IPCV);

• SMH of at least 1 disc area, involving the fovea, and of sufficient density to obscure RPE detail;

• Written informed consent to participate in the study.Only one eye will be eligible for inclusion in this study.

Exclusion criteria:

• SMH that is known to have been present for greater than 2 weeks duration, as evidenced by history, pre-trial documentation, or fundus appearance;

• Presence of significant vitreous haemorrhage precluding accurate retinal assessment in the study eye;

• Diabetic maculopathy in the study eye;

• Visually significant cataract in the study eye;

• Amblyopia in the study eye;

• Presence of other ocular disease causing concurrent vision loss in the study eye;

• Advanced glaucoma in the study eye (cup-to-disc ratio greater than 0.8);

• Pregnant and or lactating women;

• Women of childbearing potential including those who are not sterilised or at least one year post menopausal;

• Participation in a clinical interventional trial in the preceding 6 months;

• Documented evidence of a visual acuity less than 25 ETDRS letters at three consecutive visits in the study eye, prior to the onset of submacular haemorrhage;

• Participants who are known to have been ineligible for NICE approved ranibizumab therapy prior to the development of the SMH;

• Current treatment for wet age-related macular degeneration with an intravitreal agent other than ranibizumab, bevacizumab or aflibercept;

• Patients who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements.

• Patients who show insufficient understanding of the clinical trial or treatment options.