Treatment for bleeding in the eye due to wet macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of a surgical approach combined with anti-VEGF injections against the current standard treatment of anti-VEGF injections alone for patients suffering from submacular hemorrhage (SMH) due to wet age-related macular degeneration (AMD). The study will involve participants aged 50 and older who have been diagnosed with SMH and will assess visual outcomes following treatment. Participants will undergo a series of interventions including vitrectomy, subretinal tissue plasminogen activator (TPA) injection, and intravitreal gas tamponade, alongside regular anti-VEGF injections. The goal is to determine if this combined approach leads to better visual recovery compared to standard care.

Why it matters

Who can join: the full rules

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.
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.

Where it's running

• University of Bonn
  Bonn, Germany Recruiting
• University Medical Center Hamburg Eppendorf
  Hamburg, Germany Recruiting
• Eye Clinic Ludwigshafen
  Ludwigshafen, Germany Recruiting
• Ludwig Maximilians-University München
  München, Germany Recruiting
• Augenzentrum am St. Franziskus-Hospital Münster
  Münster, Germany Recruiting
• Knappschaft Kliniken Saar GmbH, Sulzbach
  Sulzbach, Germany Recruiting

Study contacts

• Principal investigator: Timothy L Jackson, PhD, FRCOphth — Kings College London & Kings College Hospital
• Study coordinator: Riti Desai, M.Sc.,M.Phil.
• Email: ritidesai@nhs.net
• Phone: 0044 2032991297

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• ETHY-001 safety and activity in Thyroid Eye Disease (TED)

  This study tests ETHY-001 versus placebo to see if it is safe, tolerable, and shows activity in people with thyroid eye disease.

  Recruiting at 2 sites Phase 1 Ethyreal Bio, Inc. · Orland Park, Illinois and 2 other locations · NCT07885605

• Autologous Serum Tears with Hyaluronate vs Standard Serum Tears for Moderate-to-Severe Dry Eye

  This study tests whether adding sodium hyaluronate to autologous serum eye drops provides better relief for adults with moderate-to-severe dry eye in one eye, compared with the standard serum drops in the other eye.

  Recruiting Phase 2 University of Miami · Miami, Florida · NCT07413172

• Two approaches to repeat eyelid surgery for post-operative trichiasis

  This project will try whether the newer Bevel-Rotate Advancement Procedure (B-RAP) or the standard Bilamellar Tarsal Rotation (BLTR) gives better results for people in Tanzania who need repeat surgery for post-operative trachomatous trichiasis.

  Recruiting at 2 sites University of North Carolina, Chapel Hill · Chapel Hill, North Carolina and 1 other locations · NCT07322302

• How TRYPTYR affects quality of life and the ability to work for people with dry eye

  This one-month test will see if TRYPTYR (acoltremon) eye drops help adults with chronic dry eye produce more tears, reduce symptoms, and improve their ability to do work.

  Recruiting at 3 sites Phase 4 Southern College of Optometry · Pittsburg, Kansas and 2 other locations · NCT07266948

• Course of EYS-associated retinitis pigmentosa in adults from Russia and former CIS

  We will follow adults with pathogenic EYS gene variants from Russia and former CIS for four years to try to find reliable vision and retinal measures for future treatments.

  Recruiting Sensor Technology for Deafblind · Moscow · NCT07228793

• Dapagliflozin (an SGLT2 inhibitor) for slowing geographic atrophy in dry AMD

  This trial will test whether taking dapagliflozin once daily can slow the growth of geographic atrophy in people aged 50 and older with dry age-related macular degeneration.

  Recruiting Phase 2 Washington University School of Medicine · St Louis, Missouri · NCT07174687

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.