A clinical trial of a clot dissolving drug and gas, injected into the eye, to treat bleeding associated with wet age-related macular degeneration

Intravitreal Tissue Plasminogen Activator (tPA), Perfluoropropane (C3F8), and Ranibizumab for Neovascular Age-Related Macular Degeneration and Submacular Haemorrhage (TAPAS): A Randomized, Double-Masked, Controlled, Factorial, Feasibility Study - TAPAS Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-004078-24-GB

Enrollment

Registered

2013-01-22

Start date

2013-01-24

Completion date

Unknown

Last updated

2025-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sub-macular haemorrhage secondary to wet macular degeneration MedDRA version: 16.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders MedDRA version: 16.0 Level: LLT Classification code 10067791 Term: Wet macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: Actilyse Product Name: Actilyse Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Proposed INN: ALTEPLASE CAS Number: 105857-23-6 Concentration unit: µg mi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adults of either sex aged 50 years and older; - SMH associated with treatment naive or previously treated wet AMD; - SMH involving the fovea and of sufficient density to obscure RPE detail. - Able to give informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 55 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 55

Exclusion criteria

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 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; - Participants who, in the opinion of the Investigator, would not be willing or able to comply with the study protocol, including posturing requirements. - Unable to give informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine if intravitreal tissue plasminogen activator (tPA), gas (C3F8) and ranibizumab promote the resolution of submacular haemorrhage (SMH) due to neovascular (wet) age-related macular degeneration, and improve the visual outcome. The primary outcome measure will be the change in mean ETDRS visual acuity at 3 months following treatment. [Lay notes: ETDRS visual acuity is vision assessed using a specialized eye chart.Please see the lay summary for the other clinical terms in this section] ;Secondary Objective: This study will provide data that will help us design a subsequent definitive trial, assuming the results of treatment are positive. It will also tell us which combination of treatments works best, so that the most appropriate treatment is selected for further study. We will also look at which clinical outcomes are best to measure, including a range of vision tests, and physical measurements of the size of the blood clot and scarring inside the eye (using photographs of the macula). ;Primary end point(s): Mean ETDRS visual acuity at 3 months.;Timepoint(s) of evaluation of this end point: 3 months	—

Measure

Time frame

Main Objective: To determine if intravitreal tissue plasminogen activator (tPA), gas (C3F8) and ranibizumab promote the resolution of submacular haemorrhage (SMH) due to neovascular (wet) age-related macular degeneration, and improve the visual outcome. The primary outcome measure will be the change in mean ETDRS visual acuity at 3 months following treatment. [Lay notes: ETDRS visual acuity is vision assessed using a specialized eye chart.Please see the lay summary for the other clinical terms in this section] ;Secondary Objective: This study will provide data that will help us design a subsequent definitive trial, assuming the results of treatment are positive. It will also tell us which combination of treatments works best, so that the most appropriate treatment is selected for further study. We will also look at which clinical outcomes are best to measure, including a range of vision tests, and physical measurements of the size of the blood clot and scarring inside the eye (using photographs of the macula). ;Primary end point(s): Mean ETDRS visual acuity at 3 months.;Timepoint(s) of evaluation of this end point: 3 months

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Secondary

Measure	Time frame
Secondary end point(s): - Mean ETDRS visual acuity at months 1 and 12 - Percentage of eyes with 15 letters or greater improvement in ETDRS distance visual acuity at month 12 - Percentage of eyes with 0 letters or greater improvement in ETDRS distance visual acuity at month 12 - Percentage of eyes with 15 letters or greater loss in ETDRS distance visual acuity at month 12 - Mean total area of macular haemorrhage on colour fundus photography at months 1, 3 and 6 - Greatest linear dimension of macular haemorrhage on colour fundus photography at month 1, 3 and 6 - Presence of subfoveal blood on colour fundus photography at month 1 - Mean central retinal thickness on optical coherence tomography at months 1 and 12 - Mean area of fibrosis on fluorescein angiography at month 12 - Greatest linear dimension of fibrosis on fluorescein angiography at month 12 - LOCSII cataract score at month 12 - Mean Pelli-Robson contrast sensitivity at months 1, 6 and 12 - Mean change in National Eye Institute Visual Function Questionnaire (VFQ25) at months 1, 3, 6 and 12;Timepoint(s) of evaluation of this end point: As above	—

Measure

Time frame

Secondary end point(s): - Mean ETDRS visual acuity at months 1 and 12 - Percentage of eyes with 15 letters or greater improvement in ETDRS distance visual acuity at month 12 - Percentage of eyes with 0 letters or greater improvement in ETDRS distance visual acuity at month 12 - Percentage of eyes with 15 letters or greater loss in ETDRS distance visual acuity at month 12 - Mean total area of macular haemorrhage on colour fundus photography at months 1, 3 and 6 - Greatest linear dimension of macular haemorrhage on colour fundus photography at month 1, 3 and 6 - Presence of subfoveal blood on colour fundus photography at month 1 - Mean central retinal thickness on optical coherence tomography at months 1 and 12 - Mean area of fibrosis on fluorescein angiography at month 12 - Greatest linear dimension of fibrosis on fluorescein angiography at month 12 - LOCSII cataract score at month 12 - Mean Pelli-Robson contrast sensitivity at months 1, 6 and 12 - Mean change in National Eye Institute Visual Function Questionnaire (VFQ25) at months 1, 3, 6 and 12;Timepoint(s) of evaluation of this end point: As above

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Countries

United Kingdom

Contacts

Public ContactTim Jackson

King's College London

t.jackson1@nhs.net00440203299 1297

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026