Study on Vitrectomy, Alteplase, and Aflibercept for Patients with Wet Age-Related Macular Degeneration and Submacular Hemorrhage

1 1 1 1

What is this study about?

This clinical trial is focused on studying a condition called exudative age-related macular degeneration (wet AMD), which is a common eye disease that can lead to vision loss in older adults. The study is exploring a new treatment approach for a specific complication of this disease known as submacular hemorrhage (SMH), where bleeding occurs under the central part of the retina, affecting vision. The treatment being tested involves a combination of surgical and medication-based interventions, including a procedure called vitrectomy, which is a surgery to remove the gel-like substance inside the eye, and the use of a medication called tissue plasminogen activator (TPA) to help dissolve the blood clot. Additionally, a gas called intravitreal SF6 is used to help the retina heal, and an injection of a medication called aflibercept (also known by code names such as BAY 86-5321) is given to help reduce abnormal blood vessel growth in the eye.

The purpose of this study is to assess the safety and effectiveness of this combined treatment approach compared to the standard treatment, which typically involves only the use of anti-VEGF medications like aflibercept. Participants in the study will be randomly assigned to receive either the new treatment combination or the standard treatment. The study will be conducted over a period of time, with regular follow-up visits to monitor the participants’ eye health and vision. During these visits, various tests will be performed to evaluate the improvement in vision and the overall health of the eye.

This trial aims to provide valuable information on whether the new treatment approach can offer better outcomes for patients with SMH due to wet AMD. The study is designed to be thorough and carefully monitored to ensure the safety of all participants. The results of this trial could potentially lead to improved treatment options for individuals affected by this challenging eye condition.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age and the condition of the eye affected by exudative age-related macular degeneration (AMD).

2 initial assessment

An initial assessment is conducted to evaluate the condition of the eye. This includes measuring the thickness of the sub-neuroretinal haemorrhage and assessing visual acuity using specific tests.

3 treatment phase

The treatment involves a surgical procedure called vitrectomy, where the vitreous gel in the eye is removed.

A medication called tissue plasminogen activator (TPA) is administered subretinally to help dissolve the haemorrhage.

An injection of SF6 gas is given intravitreally to assist in the treatment process.

Additionally, an anti-VEGF medication is administered to manage the underlying condition of AMD.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the progress of the treatment. These visits include assessments of visual acuity and the condition of the retina.

The primary goal is to achieve a gain of at least 10 letters in visual acuity by the 12-month visit.

5 final assessment

A final assessment is conducted at the end of the study period to evaluate the overall effectiveness of the treatment.

This includes measuring visual acuity, reading vision, and assessing any changes in the retina.

Who Can Join the Study?

Participants must be males or females who are at least 50 years old.
The study eye must have a condition called SMH (sub-macular hemorrhage), which is a type of bleeding under the retina. This can happen due to a condition called exudative age-related macular degeneration (AMD), which may include other issues like choroidal neovascularisation (CNV), idiopathic polypoidal choroidal vasculopathy (IPCV), or retinal angiomatous proliferation (RAP).
The SMH must involve the foveal center, which is a part of the eye important for sharp vision, and it should be at least the size of 1 disc diameter in its largest dimension.
The sub-neuroretinal hemorrhage (bleeding under the retina) must be at least 125 microns thick at the foveal center, measured using a special eye scan called spectral-domain optical coherence tomography (SD-OCT).
Participants must have a BCVA (Best Corrected Visual Acuity) between being able to count fingers and an ETDRS letter score of 70. The ETDRS is a chart used to measure vision.

Who Cannot Join the Study?

Patients who have other eye diseases that could affect the study results.
Patients who have had eye surgery recently.
Patients who are allergic to any of the study medications.
Patients who are pregnant or breastfeeding.
Patients who have a serious illness that could interfere with the study.
Patients who are unable to follow the study instructions.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Mw-Med Sp. z o.o.	Cracow	Poland

Other Sites

Site Name	City	Country
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Universitaetsklinikum Ulm AöR	Ulm	Germany
Warszawski Szpital Okulistyczny Sp. z o.o.	Warsaw	Poland
The Rotterdam Eye Hospital	Rotterdam	The Netherlands
Institute Of Eye Surgery Limited	Waterford	Ireland
Ludwig Maximilian University Of Munich	Munich	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH	Ludwigshafen Am Rhein	Germany
Knappschaft Kliniken Saar GmbH	Sulzbach	Germany
St. Franziskus-Hospital GmbH	Munster	Germany
Kpmdrvs Ojvrxmwbthre Jsvja Behref Sdw z opdw	Lodz	Poland
Sqonrahdk Rjiwhpg Uaotsdnkcf Mqfspmk Cenpwn	Nijmegen	The Netherlands
Uswimgvwfnoxyvdlvryjf Masfyhcd Azo	Munster	Germany
Udolgwznhbokhjsgzjgia Wynwablpz Abh	Wuerzburg	Germany
Ulcybscmvf Mgfwkdl Cagktt Hrnghapifrqgftzdr	Hamburg	Germany
Hzukpbnj Vacu dkypgqgb	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2023
Ireland	Recruiting	01.07.2023
Poland	Recruiting	01.07.2023
Spain	Not yet recruiting	01.07.2023
The Netherlands	Not yet recruiting	01.07.2023

Trial locations

Investigated drugs:

Tissue Plasminogen Activator (TPA) is used in this trial to help dissolve blood clots. It is administered under the retina to treat submacular hemorrhage, which is bleeding under the central part of the retina. This medication helps to clear the blood and improve vision.

SF6 Gas is a type of gas injected into the eye. It helps to hold the retina in place and can assist in the healing process after the removal of blood from under the retina. This gas is used in combination with other treatments to improve outcomes for patients with submacular hemorrhage.

Anti-VEGF Therapy involves injections into the eye to block a protein called vascular endothelial growth factor (VEGF). This protein can cause abnormal blood vessels to grow and leak, leading to vision problems. Anti-VEGF therapy helps to reduce this growth and leakage, improving vision in patients with conditions like age-related macular degeneration.

Exudative age-related macular degeneration – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and leak fluid or blood, leading to vision loss. The disease progresses as these blood vessels continue to leak, causing damage to the macula and resulting in blurred or distorted central vision. Over time, this can lead to a significant decrease in the ability to see fine details, read, or recognize faces. The condition is more common in older adults and is a leading cause of vision impairment in this age group.

Trial ID:

2023-504751-28-00

Protocol code:

TIGER

NCT ID:

NCT04663750

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider