A study of surgery to clear bleeding due to age-related macular degeneration.

Phase 1

Active, not recruiting

• Conditions: Submacular haemorrhage secondary to exudative age-related macular degeneration; MedDRA version: 20.0Level: LLTClassification code 10075718Term: Exudative age-related macular degenerationSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-004917-10-DE
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-28
• Last Update Posted: 2024-02-26

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 210

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.

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 210
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 210

Exclusion Criteria

General
1.Serious allergy to fluorescein or indocyanine green (ICG).

2.Hypersensitivity to alteplase (Actilyse), gentamicin, arginine, phosphoric acid, polysorbate 80 or aflibercept (Eylea).

3.Stroke, transient ischaemic attack or myocardial infarction within 6 months, unless both the investigator and prospective participant consider that the ocular risks of withholding intravitreal anti-VEGF therapy exceed the potential systemic risks of arteriothrombotic events that have been variably reported in association with intravitreal anti-VEGF therapy. Given the very low dose of TPA (50 micrograms versus 15 to 90 milligrams), its delivery inside the blood ocular barrier, and very short half-life, many of the systemic risks of TPA are thought unlikely to apply.

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 post IMP administration. 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,

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified