Subretinal Haematoma Linked to AMDSTARNCT02557451
Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents and Age Related Macular Degeneration Complications
A study testing Surgery, Intravitreal injections of gas and injections of an antiangiogenic in people with Subretinal Haematoma Linked to AMD, run by Centre Hospitalier Universitaire Dijon at 17 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Subretinal Haematoma Linked to AMD
- What is being tested?
- Surgery, Intravitreal injections of gas and injections of an antiangiogenic
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 17 sitesFrance
- Study dates
- 28 Apr 2016to 5 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- Patients presenting subretinal haematoma linked to AMD
- Occurring at least14 days before the start of therapy
- With the presence of a component overlying the pigmentary epithelium (PE) on the OCT
- And a diameter greater than two pupillary diameters on the retinal photographs
- Patients who have provided oral consent
- Patients with National Health Insurance cover
- Patients available for monthly follow-up
- Patient having an effective contraception for the women old enough to procreate during the treatment and during 6 months which follow his stop.
Who cannot join
- Subretinal haematoma linked to a cause other than AMD (myopia, angioid streaks…)
- History of subretinal haematoma on the same side
- Cloudy humour making it impossible to photograph the fundus of the eye or carry out angiography
- Component of the haematoma exclusively underlying the pigmentry epithelium
- Haemorrhage without lifting of the retina
- Patients presenting an INR greater than 4, thus contra-indicating surgery
Show all 13Show fewer
- Patients requiring cataract surgery in the first 3 months of the study
- Patients presenting a contra-indication relative to injection of the antiangiogenic (History of AVC bleeding or unknown origin in the last 6 months or MI in the 3 preceding months)
- Pregnant or breast-feeding woman (the patients do not have to breast-feed during at least 6 months after the administration of the last dose of the antiangiogénique)
- Contraindication in the use of ranibizumab: hypersensitivity in the active ingredient or in one of the excipients, eye infection or périoculaire active or suspected, inflammation intraoculaire active severe, treatments anti-VEGF systematic or eye concomitant,
- Contraindication in the use of bevacizumab: hypersensitivity in the active substance or in one of the excipients, the hypersensitivity in the products of the ovarian cells of Chinese hamster (CHO) or in other antibodies human or humanized recombinants, heavy surgical operation dating less than 28 days, not totally healed surgical wound, history of lung bleeding or hémoptysie
- Contraindication in the use of alteplase: hypersensitivity in the active substance, in the gentamicine (a residue of the present manufacturing process in the state of tracks), or in one of the excipients. As all the thrombolytic agents, contraindication in every case associated to a high hemorrhagic risk (current significant hemorrhagic disorder or during the last six months, hemorrhagic known diathesis, concomitant treatment by oral anticoagulants with effective dose, severe or potentially dangerous, obvious or recent bleeding, histories or suspicion of intra-cranial bleeding, suspicion of sub-arachnoid bleeding or history of sub-arachnoid bleeding bound to an aneurysm, histories of severe lesion of the central nervous system (for example néoplasie, aneurysm, surgical operation intracerebral or intrathecal), recent traumatic external cardiac massage (less than 10 days), delivery, recent draining of a vessel not accessible to the compression (for example draining of the subclavian or jugular vein),severe uncontrolled high blood pressure, bacterial endocarditis, pericarditis, acute pancreatitis, gastrointestinal ulcers documented during the last 3 months, esophageal varices, arterial aneurysm, arterial or venous deformations, neoplasia increasing the hemorrhagic risk, severe hepatic disease, including hepatic insufficiency, cirrhosis, portal hypertension (esophageal varicose veins) and evolutionary hepatitis, surgical operation or important traumas during the last 3 months.
- Contraindication in the use of acetazolamide: hypersensitivity in the acetazolamide or in one of excipients, severe hepatic, renal or suprarenal inadequacies, intolerance in sulphonamide, histories of renal colic, allergy in the wheat (other than the coeliac disease).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CHU de BESANCON
Besançon, 25030
CHU de Bordeaux
Bordeaux, 33000
CH de COLMAR
Colmar, 68000
CHI de CRETEIL
Créteil, 94000
CHU de DIJON
Dijon, 21079
CHU de GRENOBLE
Grenoble, 38043
HCL - Hôpital de la Croix-Rousse
Lyon, 69004
CHR de METZ-THIONVILLE
Metz, 57085
CH de MULHOUSE
Mulhouse, 68100
CH de NEVERS
Nevers, 58000
AP-HP Hôpital Lariboisière
Paris, 75010
Fondation Ophtalmologique A. de Rothschild
Paris, 75019
CHU de REIMS
Reims, 51092
Clinique Mathilde
Rouen, 76100
NHC de STRASBOURG
Strasbourg, 67091
CHU de TOULOUSE - Hôpital Purpan
Toulouse, 31300
CHU de NANCY
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Subretinal Haematoma in AMD: Randomized Controlled Study of 2 Therapeutic Approaches in the Antiangiogenic Era
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.
- Conditions
- Subretinal Haematoma Linked to AMD
- Being tested
- Surgery, Intravitreal injections of gas, injections of an antiangiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
Intravitreal injections of gasOther
injections of an antiangiogenicProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| surgery + antiangiogenic | Experimental | surgery (vitrectomy - air - TPA) with injections of an antiangiogenic Receives: Other: Surgery; Procedure: injections of an antiangiogenic |
| intravitreal injection of gas/TPA + antiangiogenic | Experimental | intravitreal injection of gas - TPA with injections of an antiangiogenic Receives: Other: Intravitreal injections of gas; Procedure: injections of an antiangiogenic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity measured on the ETDRS scale
Measured: Change from inclusion at 3 months
Secondary outcomes (7)
Visual acuity measured on the ETDRS scale
Measured: At 1 month and 6 months
Area of the scotoma presented by the patient according to the Amsler grid
Measured: At 1 month, 3 months and 6 months
Quality of life using the VFQ-25 scale
Measured: At 3 months and 6 months
Number of injections of an antiangiogenic at the end of the 6 months of treatment
Measured: At 6 months
Number of patients with macular bleeding
Measured: At 6 months
Area of hypoautofluorescence using the autofluorescence technique
Measured: At 3 and 6 months
Complications rate
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study start28 Apr 2016
- Primary completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subretinal Haematoma Linked to AMDStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557451
- Sponsor's protocol ID
- BRON PHRC I 2013
- Acronym
- STAR
- Status last verified
- Feb 2026
- First submitted
- 16 Sep 2015
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Gabrielle PH, Delyfer MN, Glacet-Bernard A, Conart JB, Uzzan J, Kodjikian L, Arndt C, Tadayoni R, Soudry-Faure A, Creuzot Garcher CP. Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration. Ophthalmology. 2023 Sep;130(9):947-957. doi: 10.1016/j.ophtha.2023.04.014. Epub 2023 Apr 22.
PubMed 37088447Gabrielle PH, Eid P, Aho LS, Kodjikian L, Souied E, Uzzan J, Conart JB, Delyfer MN, Creuzot-Garcher C. Prognostic Factors in Patients With Submacular Haemorrhage Complicating Age-Related Macular Degeneration: A Post Hoc Analysis of the STAR Study. Clin Exp Ophthalmol. 2026 May-Jun;54(4):492-499. doi: 10.1111/ceo.70094. Epub 2026 Feb 24.
PubMed 41734820
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subretinal Haematoma in AMD: Randomized Controlled Study of 2 Therapeutic Approaches in the Antiangiogenic Era
- ClinicalTrials.gov ID
- NCT02557451
- Acronym / sponsor ID
- STAR / BRON PHRC I 2013
- Conditions
- Subretinal Haematoma Linked to AMD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 5 May 2020 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery + antiangiogenic | Experimental | Other: Surgery, Procedure: injections of an antiangiogenicsurgery (vitrectomy - air - TPA) with injections of an antiangiogenic |
| intravitreal injection of gas/TPA + antiangiogenic | Experimental | Other: Intravitreal injections of gas, Procedure: injections of an antiangiogenicintravitreal injection of gas - TPA with injections of an antiangiogenic |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients presenting subretinal haematoma linked to AMD
- Occurring at least14 days before the start of therapy
- With the presence of a component overlying the pigmentary epithelium (PE) on the OCT
- And a diameter greater than two pupillary diameters on the retinal photographs
- Patients who have provided oral consent
Key exclusion criteria (13 listed)
- Subretinal haematoma linked to a cause other than AMD (myopia, angioid streaks…)
- History of subretinal haematoma on the same side
- Cloudy humour making it impossible to photograph the fundus of the eye or carry out angiography
- Component of the haematoma exclusively underlying the pigmentry epithelium
- Haemorrhage without lifting of the retina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery | Other | surgery + antiangiogenic |
| Intravitreal injections of gas | Other | intravitreal injection of gas/TPA + antiangiogenic |
| injections of an antiangiogenic | Procedure or surgery | intravitreal injection of gas/TPA + antiangiogenic, surgery + antiangiogenic |
Primary outcome
Visual acuity measured on the ETDRS scale
Time frame: Change from inclusion at 3 months
7 secondary outcomes
Visual acuity measured on the ETDRS scale
Time frame: At 1 month and 6 months
Area of the scotoma presented by the patient according to the Amsler grid
Time frame: At 1 month, 3 months and 6 months
Quality of life using the VFQ-25 scale
Time frame: At 3 months and 6 months
Number of injections of an antiangiogenic at the end of the 6 months of treatment
Time frame: At 6 months
Number of patients with macular bleeding
Time frame: At 6 months
Area of hypoautofluorescence using the autofluorescence technique
Time frame: At 3 and 6 months
Complications rate
Time frame: At 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 37088447Gabrielle PH, Delyfer MN, Glacet-Bernard A, Conart JB, Uzzan J, Kodjikian L, Arndt C, Tadayoni R, Soudry-Faure A, Creuzot Garcher CP. Surgery, Tissue Plasminogen Activator, Antiangiogenic Agents, and Age-Related Macular Degeneration Study: A Randomized Controlled Trial for Submacular Hemorrhage Secondary to Age-Related Macular Degeneration. Ophthalmology. 2023 Sep;130(9):947-957. doi: 10.1016/j.ophtha.2023.04.014. Epub 2023 Apr 22.
- Derived from this study: PubMed 41734820Gabrielle PH, Eid P, Aho LS, Kodjikian L, Souied E, Uzzan J, Conart JB, Delyfer MN, Creuzot-Garcher C. Prognostic Factors in Patients With Submacular Haemorrhage Complicating Age-Related Macular Degeneration: A Post Hoc Analysis of the STAR Study. Clin Exp Ophthalmol. 2026 May-Jun;54(4):492-499. doi: 10.1111/ceo.70094. Epub 2026 Feb 24.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery, Intravitreal injections of gas and injections of an antiangiogenic in people with Subretinal Haematoma Linked to AMD, run by Centre Hospitalier Universitaire Dijon at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity measured on the ETDRS scale (time frame: Change from inclusion at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557451, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.