To compare visual outcome and foveal function after (initiation of) treatment between patients receiving an RPE-choroid graft and patients with anti-VEGF medication.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Visual acuity, reading vision and foveal fixation at 1 years.
Secondary outcome
VA and reading vision at 2 years.
IOP.
Background summary
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.
Study objective
To compare visual outcome and foveal function after (initiation of) treatment
between patients receiving an RPE-choroid graft and patients with anti-VEGF
medication.
Study design
Prospective, international multicenter, randomized intervention study.
Intervention
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.
Study burden and risks
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 protocol. 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.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
- informed consent
- age >= 65 years
- AMD 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.
- visual acuity of 20/63 to 20/800.
- recent (< 3 months) activity of the lesion
- myopia < -8 D
- clear media to permit fundus photography, FAG, ICG-A and OCT
- capable to follow instructions
- anticoagulant drugs can be discontinued during 6 weeks
Exclusion criteria
- haemorrhage or PED secondary to:
1 retinal angiomatous proliferation,
2 aneurysm,
3 CNV associated with high myopia,
4 polypoidal choriodopathy.
- hypersensitivity to humanized monoclonal antibodies
- current acute ocular or peri-ocular infection
- any major surgical procedure (scheduled) within 1 month of study entry not related to this study, cataract surgery excepted.
- serious allergy to fluorescein or indocyanine green dye
- significant other ocular disorders affecting visual acuity
- immunocompromised
- current treatment for active systemic infection
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2008-008259-41-NL |
| CCMO | NL26302.078.08 |