|- candidate number||5632|
|- NTR Number||NTR1768|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-apr-2009|
|- Secondary IDs||2008-20 / 26302.078.08 OZR / NL |
|- Public Title||Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.|
|- Scientific Title||Anti-VEGF (bevacizumab/ranibizumab) versus RPE-choroid graft in the treatment of 1) non-responders to 3 intravitreal anti-VEGF injections, or 2) patients with AMD and pigment epithelium rip, or 3) patients with AMD and massive haemorrhage. A randomized trial.|
|- hypothesis||Visual outcome in patients receiving RPE-choroid graft will be better than in patients receiving anti-VEGF medication.|
|- Healt Condition(s) or Problem(s) studied||Macular degeneration|
|- Inclusion criteria||1. Informed consent;|
2. Age > 65 years;
3. AMD in combination with either of the following conditions:
A. Visual loss of > 15 letters on the ETDRS chart after 3 anti-VEGF injections;
B. Subfoveal RPE-tear;
C. Massive submacular haemorrhage;
D. Visual acuity of 20/63 to 20/800.
4. History or examination must indicate recent (< 3 months) activity of the lesion;
5. Myopia < -8 D;
6. Clear media to permit fundus photography, FAG, ICG-A and OCT;
7. Capable to follow instructions;
8. Willing and physically able to complete study visits during at least 12 months;
9. Anticoagulant drugs (Coumarin, antiplatelet agents) can be discontinued during 6 weeks.
|- Exclusion criteria||1. Haemorrhage or PED secondary to:|
A. Retinal angiomatous proliferation;
C. CNV associated with high myopia;
D. Polypoidal choriodopathy;
E. Known hypersensitivity to humanized monoclonal antibodies;
F. Current acute ocular or peri-ocular infection;
G. Any major surgical procedure (scheduled) within 1 month of study entry not related to this study, cataract surgery excepted.
2. Known serious allergy to fluorescein or indocyanine green dye;
3. Significant other ocular disorders affecting visual acuity;
5. Current treatment for active systemic infection.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||30-apr-2014|
|- Target number of participants||240|
|- Interventions||RPE-choroid graft, intravitreal anti-VEGF injection.|
|- Primary outcome||1. Visual acuity (lines lost or gained on ETDRS chart) at one year after initial treatment;|
2. Foveal fixation;
3. Reading vision (in Austria, Germany and The Netherlands, the Radner chart will be used; in France and Italy the Parinaud chart; in London Jaeger chart) at one year.
|- Secondary outcome||1. VA at 2 years;|
2. Reading vision at 2 years;
|- Timepoints||Baseline, 12 months, 24 months.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES||Dr. J.C. Meurs, van|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.C. Meurs, van|
|- Sponsor/Initiator ||Oogziekenhuis Rotterdam (OZR)|
(Source(s) of Monetary or Material Support)
|Stichting Wetenschappelijk Onderzoek het Oogziekenhuis|
|- Publications||van Zeeburg EJ, Maaijwee K, van Meurs JC. There is no relation
between the occurrence of proliferative vitreoretinopathy and the
location of the donor site after transplantation of a free autologous retinal
pigment epithelium-choroid graft. Acta Ophthalmol. 2014; 92(3): 228-
231. PMID: 23890210|
|- Brief summary||Rationale:|
Standard treatment for patients with exudative age-related macular degeneration (AMD) is intravitreal injection of anti-VEGF. Because alternatives are not available, at present, also those patients for whom this therapy probably does not help to improve prospects are initially treated with anti-VEGF. Recently, however, it has been shown that a retinal pigment epithelium (RPE)-choroid graft translocation in the treatment of patients with choroidal neovascular lesions of AMD can stabilize or even improve visual acuity. In this study, it will be investigated whether RPE-choroid graft translocation provides a better alternative to anti-VEGF medication for AMD patients for whom prospects are rather poor otherwise.
To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
Prospective, international multicenter, randomized intervention study.
Patients with exudative AMD, aged 65 years or older, in combination with either of the following conditions: 1) visual loss of > 15 letters on the ETDRS chart after 3 anti-VEGF injections, 2) subfoveal RPE-tear, 3) massive submacular haemorrhage.
Arm 1: RPE-choroid graft translocation.
Arm 2: intravitreal anti-VEGF (Avastin or Lucentis) injections (PrONTO protocol).
Irrespective of study arm, blood will always be surgically removed in patients with massive haemorrhage.
Main study parameters:
Visual acuity, reading vision and foveal fixation at 1 and 2 years.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
Prognosis for exudative AMD complicated by RPE-rip or massive haemorrhage, and for non-responders to anti-VEGF therapy, is very poor. At this moment the only available alternative option for treatment may be an RPE-choroid graft translocation. It has been shown that with this technique vision loss can be limited. The RPE-choroid graft arm requires two surgical procedures (local or general anaesthesia), i.e. one for the translocation procedure and a second to remove silicone oil. Complications consist of retinal detachment (8%), recurrence of CNV (13%) and haemorrhage (10%). Massive haemorrhage will always be surgically removed (arm 1: in combination with the first surgical procedure, i.e. the RPE-choroid graft; in arm 2: as single surgical procedure). The risk of complications of haemorrhage removal alone (arm 2) will be less than in combination with the transplantation part.The anti-VEGF arm receives intravitreal injections (topical anaesthesia) in accordance with the PrONTO protocol24. Most patients will receive an injection once every two or three months. Repeated intravitreal anti-VEGF injections pose a (cumulative) risk for endophthalmitis. Each injection is associated with a risk of 0.1% to develop endophthalmitis. Number of visits during year 1 will be 11 (arm 1) and 8 (arm 2) respectively.
|- Main changes (audit trail)|
|- RECORD||20-apr-2009 - 12-sep-2014|