Phase 3 Study Comparing Surgery Plus Anti-VEGF Injections Versus Anti-VEGF Alone for Submacular Hemorrhage in Wet Age-Related Macular Degeneration

What this Trial Is About

This research aims to evaluate treatments for submacular haemorrhage SMH, a severe complication of wet age-related macular degeneration AMD that can cause significant and lasting vision loss. Wet AMD damages cells in the retinas central part called the macula, leading to abnormal blood vessel growth and fluid leakage. The study compares the current standard treatment using anti-VEGF eye injections to a combination of this treatment with surgery to see if vision can be improved further. Participants will be randomly assigned to one of two groups. One group will receive anti-VEGF injections alone, starting at baseline and continuing monthly for two doses, then every two months up to 12 months. The other group will have surgery involving vitrectomy to remove the eyes gel, an injection of a clot-breaking drug TPA, and a gas bubble placed inside the eye to help clear the blood clot, combined with the same anti-VEGF injection schedule starting at surgery. Surgery patients will follow specific head positioning instructions for five days post-operation and attend follow-up visits the day after surgery and one week later. Throughout the study, participants will have regular vision tests and clinical exams at baseline, 6 months, and 12 months, as well as ongoing anti-VEGF injections. Researchers will assess vision improvements using detailed visual acuity tests and questionnaires about visual function and quality of life. The study will monitor participants vision changes, side effects, and overall eye health over the one-year duration to determine whether surgery plus injections offers better outcomes than injections alone.

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