NCT02557451: STAR

Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration Complications

Completed NA Last updated 9 February 2026

What this trial tests

NA trial testing Surgery in Subretinal Haematoma Linked to AMD in 91 participants. Completed.

Timeline

28 April 2016

Primary endpoint
5 May 2020

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Enrollment	91
Start date	28 April 2016
Primary completion	5 May 2020
Sites	17 locations across France

Drugs / interventions tested

• Surgery
• Intravitreal injections of gas
• injections of an antiangiogenic

Conditions studied

• Subretinal Haematoma Linked to AMD — all drugs for Subretinal Haematoma Linked to AMD →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

50 and older, any sex, with Subretinal Haematoma Linked to AMD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

AMD is a disease of the central retina, a zone that enables fine detail activities (reading, detail…). This central zone of the retina can be affected by a haemorrhagic complication when small abnormal vessels suddenly start to bleed inside the retina. Several therapeutic approaches are currently available even though they have never been truly compared. The study will be proposed to patients who need to be treated for haemorrhage of the macula. A certain number of factors will be evaluated to compare the 2 principal approaches currently used in France: surgery followed by injections of an anti-angiogenic OR intravitreal injections of gas followed by injections of anti-angiogenics. This is a multicentre, randomized controlled trial to compare these 2 therapeutic approaches.

These diametrically opposed approaches have very different consequences for patients and in terms of cost for society. The consequences for patients will be immediately measurable so as to determine the best therapeutic approach in terms of functional recovery and the impact of the disease on quality of life, while taking into account the risks inherent to these 2 treatments. The impact on quality of life of these 2 approaches as well as their consequences - an important factor in this disease, which is a cause of sensory handicap - will provide the ophthalmological community with essential information making it possible to validate one or the other of these methods for the management of these haematomas.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Vitrectomy, subretinal Tissue plasminogen activator and Intravitreal Gas for submacular haemorrhage secondary to Exudative Age-Related macular degeneration (TIGER): study protocol for a phase 3, pan-European, two-group, non-commercial, active-control, observer-masked, superiority
   Jackson TL, Bunce C, Desai R, Hillenkamp J, et al · · 2022 · cited 27× · PMID 35101110 · DOI 10.1186/s13063-021-05966-3
2. Comparison of treatment methods for submacular hemorrhage in neovascular age-related macular degeneration: conservative versus active surgical strategy.
   Mun Y, Park KH, Park SJ, Cho HJ, et al · · 2022 · cited 9× · PMID 36050401 · DOI 10.1038/s41598-022-18619-5
3. Prognostic Factors in Patients With Submacular Haemorrhage Complicating Age-Related Macular Degeneration: A Post Hoc Analysis of the STAR Study.
   Gabrielle PH, Eid P, Aho LS, Kodjikian L, et al · · 2026 · PMID 41734820 · DOI 10.1111/ceo.70094