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Intravitreal versus submacular injection of rtPA for acute submacular haemorrhages.


- candidate number12082
- NTR NumberNTR3359
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-mrt-2012
- Secondary IDs2010-22 / NL34560.078.10; METC OZR / CCMO
- Public TitleIntravitreal versus submacular injection of rtPA for acute submacular haemorrhages.
- Scientific TitleIntravitreal versus submacular injection of rtPA for acute submacular haemorrhages.
- ACRONYM
- hypothesisSubmacular administration of rtPA for submacular haemorrhages is safe and effective.
- Healt Condition(s) or Problem(s) studiedAcute submacular haemorrhages.
- Inclusion criteria1. Informed consent;
2. Age > 45;
3. Submacular haemorrhage not existing longer than 14 days at time of surgery;
4. A clinically relevant SMH that needs treatment;
5. If patient is on anticoagulant drugs: INR<2 (measured during preoperative holding).
- Exclusion criteria1. INR>2 (or when treating cardiologist does not allow an INR<2);
2. Known etiology of SMH other than exudative AMD;
3. Known serious allergy to fluorescein or indocyanine green dye;
4. Immunocompromised.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2012
- planned closingdate1-sep-2014
- Target number of participants24
- InterventionsStudy arm 1: Submacular rtPA with pars plana vitrectomy, intravitreal C3F8/air mixture and bevacizumab.
Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.
- Primary outcome1. Location of haemorrhage at baseline and 6 weeks;
2. Size of haemorrhage at baseline and 6 weeks;
3. Safety at 6 weeks.
- Secondary outcome1. Location and size of haemorraghe at 12 weeks (at ophthalmologists' discretion);
2. Visual acuity (ETDRS chart) at baseline 6 and 12 weeks.
- TimepointsBaseline, day 0, day 1, weeks 2, 4, 5, 6, 10 and 12.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. J.C. Meurs, van
- CONTACT for SCIENTIFIC QUERIESDr. J.C. Meurs, van
- Sponsor/Initiator The Rotterdam Eye Hospital
- Funding
(Source(s) of Monetary or Material Support)
Stichting Wetenschappelijk Onderzoek Oogziekenhuis Prof. Dr. Flieringa (SWOO)
- Publicationsde Jong JH, van Zeeburg EJ, Cereda MG, van Velthoven ME, Faridpooya K, Vermeer KA, van Meurs JC. Intravitreal versus subretinal administration of recombinant tissue plasminogen activator combined with gas for acute submacular hemorrhages due to age-related macular degeneration: An Exploratory Prospective Study. Retina. 2016; 36(5): 914-925
- Brief summaryRationale:
Submacular haemorrhage (SMH) is a severe complication of age-related macular degeneration (AMD). Anti-VEGF injections, the current standard treatment for exudative AMD, appear to be ineffective when a (large) SMH is present. If untreated, the SMH itself will cause irreversible damage to the retina and retinal pigment epithelium (RPE). Two treatment modalities of SMH will be compared.

Objective:
To examine which administration route of recombinant tissue plasminogen activator (rtPA) is safe and effective.

Study design:
Prospective, randomized, explorative intervention study.

Study population:
Consecutive patients with SMH existing 14 days at time of surgery.

Intervention:
Study arm 1: Submacular rtPA with pars plana vitrectomy (ppV), intravitreal C3F8/air mixture and bevacizumab.
Study arm 2: Intravitreal rtPA, C3F8 gas and bevacizumab.

Main study parameters:
Location and size of haemorrhage at 6 weeks.

Safety, Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
It is not clear, in advance, whether intravitreal or subretinal administration of rtPA is superior with respect to efficacy and safety. It is assumed that the minimally invasive treatment has a smaller effect on resorption and/or relocation of the blood but involves a lower risk of complications, while the maximally invasive treatment has a stronger effect on the SMH but involves a higher risk of complications. There will be 7 visits involving study-related assessments for both study arms: i.e. pre-operative, surgery, post-operative day 1, week 2, 4, 6, 12.
- Main changes (audit trail)
- RECORD19-mrt-2012 - 22-okt-2017


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