Vitrectomy, Subretinal Tissue Plasminogen Activator (TPA) and Intravitreal Gas for Submacular Haemorrhage Secondary to Exudative (Wet) Age-related Macular Degeneration (TIGER).

Launched by KING'S COLLEGE HOSPITAL NHS TRUST · Dec 10, 2020

Keywords

ClinConnect Summary

The TIGER clinical trial is looking at two different treatment approaches for people with a specific eye condition called wet age-related macular degeneration (AMD), which can lead to bleeding under the macula—a part of the retina responsible for our central vision. The standard treatment for wet AMD includes injections that help reduce fluid leakage and improve vision. This study aims to find out if adding surgery to these injections can help improve vision even more for individuals experiencing a type of bleeding known as submacular hemorrhage (SMH).

To participate in this trial, you must be at least 50 years old and have SMH caused by wet AMD that affects your central vision. Participants will receive either the standard injections alone or the injections along with surgery. Throughout the trial, you can expect regular check-ups to assess your vision and overall progress. If you're considering joining, it's important to know that certain medical conditions or recent treatments may affect your eligibility. This trial is a valuable opportunity to help improve treatments for those with wet AMD and related vision issues.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • General
• • 1. Males or females aged at least 50 years
• • Study eye
• • 2. 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 polypoidal choroidal vasculopathy (IPCV) and retinal angiomatous proliferation (RAP).
• • 3. SMH involving the foveal centre that measures at least 1 disc diameter in greatest linear dimension.
• • 4. Sub-neuroretinal haemorrhage at least 125 microns thick, measured at the foveal centre using spectral-domain optical coherence tomography (SD-OCT).
• • 5. BCVA between counting fingers and an Early Treatment of Diabetic Retinopathy Study (ETDRS) letter score of 70, inclusive.
• Exclusion Criteria:
• • General
• • 1. Serious allergy to fluorescein or indocyanine green (ICG).
• • 2. Hypersensitivity to alteplase, gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept (Eylea).
• • 3. Stroke, transient ischaemic attack or myocardial infarction within 6 months.
• • 4. Participation in another interventional study within 12 weeks of enrolment or planned to occur during this study.
• • 5. 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 use highly effective methods of birth control for the duration up to 12 weeks after administration of IMP or the last administration of aflibercept on the trial. Men must also agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy. Females of childbearing potential are females who have experienced menarche and are not surgically sterilised (e.g. hysterectomy or bilateral salpingectomy) or post-menopausal (defined as at least 1 year since last regular menstrual period). Highly effective methods of birth control are those with a failure rate of \< 1% per year when employed consistently and correctly, eg. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation via oral, intravaginal, and transdermal routes; progestogen-only hormonal contraception associated with inhibition of ovulation via oral, injectable, implantable, intrauterine device (IUD), or intrauterine hormone-releasing system ( IUS); or vasectomised partner.
• • 6. 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\*.
• • 7. Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
• • 8. 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 disease.
• • Study eye
• • 9. 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.
• • 10. SMH due to eye disease other than exudative AMD.
• • 11. Current active proliferative diabetic retinopathy.
• • 12. Current intraocular inflammation.
• • 13. Current ocular or periocular infection other than blepharitis.
• • 14. Current or known former high myopia (\>6 dioptres).
• • 15. Aphakia.
• • 16. 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 amblyopia, macular hole involving the fovea, or very poor BCVA prior to presentation with SMH (counting fingers or worse).
• • 17. Inadequate pupillary dilation or significant media opacities, which will prevent adequate clinical evaluation of the posterior segment or fundus imaging.
• • 18. 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.