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New treatment option for Eye Diseases
Official title Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).
ClinicalTrials.gov ID: NCT04663750
What this study is testing
What is Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12?
Intravitreal 2 mg aflibercept will be injected at baseline then monthly for two further doses, then 2-monthly until month 12 is an investigational medicine, given as a monthly treatment applied to the skin, being studied as a potential treatment for eye diseases.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The centre of the retina (macula) at the back of the eye contains cells that give us our central vision that we use for reading and recognising faces. These cells can be damaged by a disease called wet age-related macular degeneration (AMD), where new abnormal blood vessels grow through the macula and leak fluid.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 120
You may be able to join if
- General
- Males or females aged at least 50 years Study eye
- SMH, comprising sub-neuroretinal haemorrhage with or without sub-RPE haemorrhage, that occurs secondary to treatment naïve, or previously treated...
- SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension.
- Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT).
You likely can't join if
- General
- Serious allergy to fluorescein or indocyanine green (ICG).
- Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept.
- Stroke, transient ischaemic attack or myocardial infarction within 6 months.
- Participation in another treatment study within 12 weeks of enrolment or planned to occur during this study.
- Women who are breast feeding, pregnant, or planning to become pregnant during the clinical trial. Any sexually active women of childbearing potential...
See the full eligibility criteria
- General
- Males or females aged at least 50 years Study eye
- SMH, comprising sub-neuroretinal haemorrhage with or without sub-RPE haemorrhage, that occurs secondary to treatment naïve, or previously treated exudative AMD, including choroidal neovascularisation (CNV), idiopathic...
- SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension.
- Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT).
- BCVA between counting fingers and an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 70, inclusive.
- General
- Serious allergy to fluorescein or indocyanine green (ICG).
- Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept.
- Stroke, transient ischaemic attack or myocardial infarction within 6 months.
- Participation in another treatment study within 12 weeks of enrolment or planned to occur during this study.
- Women who are breast feeding, pregnant, or planning to become pregnant during the clinical trial. Any sexually active women of childbearing potential must agree continued abstinence from heterosexual intercourse or to...
- International Normalised Ratio (INR) greater than 3.5, unless it is anticipated that the INR can be brought below this level prior to vitrectomy, balancing the systemic risks with those of intraocular haemorrhage\ .
- Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
- Any other condition which, in the opinion of the investigator, would prevent the participant from granting informed consent or complying with the protocol, such as dementia, mental illness, or serious systemic medical...
- SMH that is known or estimated to have been present for longer than 15 days, as evidenced by history, pre-trial clinical documentation, or fundus appearance.
- SMH due to eye disease other than exudative AMD.
- Current active proliferative diabetic retinopathy.
- Current intraocular inflammation.
- Current ocular or periocular infection other than blepharitis.
- Current or known former high myopia (\>6 dioptres).
- Aphakia.
- Other current or pre-existing ocular conditions that, in the opinion of the Investigator, will preclude any improvement in BCVA following resolution of SMH, such as severe central macular atrophy or fibrosis, dense...
- Inadequate pupillary dilation or significant media opacities, which will prevent adequate clinical evaluation of the posterior segment or fundus imaging.
- Intraocular surgery within 12 weeks of enrolment except for uncomplicated cataract surgery, which is permitted within 8 weeks of enrolment.
- Applies only to participants receiving warfarin.
The study team makes the final eligibility decision.
Where it's taking place
- Bonn, Germany
- Hamburg, Germany
- München, Germany
- Münster, Germany
- Sulzbach, Germany
- Ulm, Germany
- Würzburg, Germany
- Waterford, Ireland
- Lodz, Poland
- Bern, Switzerland
- Chelmsford, Essex, United Kingdom
- Canterbury, Kent, United Kingdom
- London, London, United Kingdom
- Edinburgh, Scotlan, United Kingdom
- Sunderland, Tyne and Wear, United Kingdom
- Hull, Yorkshire, United Kingdom
- Belfast, United Kingdom
- Brighton, United Kingdom
- Bristol, United Kingdom
- Exeter, United Kingdom
+ 14 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bonn, Germany; Hamburg, Germany; München, Germany; Münster, Germany; Sulzbach, Germany; Ulm, Germany and 28 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.