The primary objective of this study is to estimate the incidence of ocular adverse events in patients with CNV secondary to AMD who receive an individualized treatment with ranibizumab 0,3 mg.
ID
Source
Brief title
Condition
- Retina, choroid and vitreous haemorrhages and vascular disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Safety: incidence of Grade 3 targeted adverse events over the one year
treatment period.
Secondary outcome
Efficacy: mean change in best corrected visual acuity and retinal thickness and
time to first re-treatment and total number of treatments.
Safety: all other adverse events, heart rate and blood pressure and the results
of the ophthalmic examinations
Background summary
Age related macula degeneration (AMD) is one of the most important causes of
irreversible vision loss in individuals older than 50 years of age. Because the
amount of older individuals will continue to grow, AMD will become a bigger
problem for the public health in the future.
Usually the treatment of AMD is only possible in a limit amount of cases of
subfoveal choroidal neovascularization (CNV) secundairy to AMD. The treatment
is considered to be successful if the visual acuity decreases less fast than
without treatment. Often it is not possible to improve the visual acuity. With
laser treatment the leaking blood vessels are closed en sometimes further
bleedings and deterioration of the eye sight can be prevented. But also in this
situation it can not be guaranteed that the effects remain positive. Treatment
with radiotherapy is thoroughly examined. At short notice only a limited group
of patients with CNV secondiary to AMD react positive on radiotherapy.
Photodynamic therapy can be successful in a selective group of patients with
CNV secondairy to AMD. With this therapy the leaking blood vessels are treated
and worsening of the visual acuity is decreased. At this moment the efficacy of
several different compounds that inhibit the grow of new blood vessels are
being tested in patients with CNV secondairy to AMD. Ranibizumab is also known
to inhibit the grow of new blood vessels.
Study objective
The primary objective of this study is to estimate the incidence of ocular
adverse events in patients with CNV secondary to AMD who receive an
individualized treatment with ranibizumab 0,3 mg.
Study design
This is phase IIIb, open label, multi-centre study.
The study consists of 2 periods: the screening period of maximal 2 weeks in
which is determined if the patient meets all in, - and exclusion criteria, and
the treatment period of 12 months. In this treatment period the investigator
decides how many visits to the physician are necessary, which examinations have
to be done during the visits and how often the patient is treated with
ranibizumab, based on the status of the AMD and the adverse events. In total
the patient has to visit the physician minimal 7 and maximal 15 times.
Intervention
During the study all patients will be treated with ranibizumab 0,3 mg.
Study burden and risks
During the study all patients are treated with ranibizumab. To prevent eye
infections caused by the injections, patients have to administer antibiotics in
the eye before and after the injections.
In the beginning of the treatment period the patients will visit the physician
on a monthly basis. Later the patients will visit the physician as needed,
based on the opinion of the investigator. During these visits several eye
examinations are done. There is a chance that the vision might worsen as a
result of progression of the AMD, to a side effect of the injection or to other
reasons.
There is a remote chance to experience an allergic reaction to ranibizumab,
such as skin rash, hives or possibly more serious problems such as breathing
difficulties or shock. An allergic reaction can also cause dry or itchy eyes.
Raapopseweg 1
6824 DP Arnhem
Nederland
Raapopseweg 1
6824 DP Arnhem
Nederland
Listed location countries
Age
Inclusion criteria
1. Male or female patients >50 years of age
2. Diagnosis of active primary or recurrent CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component
3. The total area of CNV encompassed within the lesion must be > or equal 50% of the total lesion area
4. The total lesion area must be <= 12 disc areas
5. Patients who have a BCVA score between 73 and 24 letters, inclusive, in the study eye using ETDRS-like grading charts
6. Expectation by the investigator that patients will potentially benefit from ranibizumab treatment
Exclusion criteria
1. Previous treatment with intravitreally or intravenously administered Avastin * (bevacizumab)
2. Laser photocoagulation, treatment with intravitreal steroids, verteporfin photo dynamic therapy (Visudyne®) or pegaptanib sodium (Macugen®) in the study eye within 30 days preceding Day 1
3. Prior treatment in the study eye with external-beam radiation therapy, vitrectomy, or transpupillary thermotherapy.
4. History of surgical intervention in the study eye within two months preceding Day 1
5. Previous participation in any studies of investigational drugs within one month preceding Day 1
6. Concurrent use of systemic anti-VEGF agents
7. Current use of or likely need for systemic medications known to be toxic to the lens, retina or optic nerve.
8. Concomitant use of chronic NSAIDs for more than seven consecutive days or systemic or topical ocular corticosteroids for three or more consecutive days within six months prior to screening) or at any time during the study.
9. Previous treatment with or participation in a clinical trial involving anti angiogenic drugs
10. Ocular disorders in the study eye that may confound interpretation of study results,
11. Concurrent disease in the study eye that could compromise visual acuity or require medical or surgical intervention during the 12-month study period
12. Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole in the study eye
13. Presence of retinal pigment epithelial tear involving the macula in the study eye
14. History of idiopathic or autoimmune-associated uveitis in either eye
15. Active infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye.
16. History of glaucoma filtration surgery or corneal surgery
17. Extracapsular extraction of cataract with phacoemulsification within 2 months preceding Day 1, or a history of post-operative complications within the last 12 months preceding Day 1 in the study eye.
18. Uncontrolled glaucoma in the study eye
19. Aphakia or absence of the posterior capsule in the study eye.
20. Spherical equivalent of the refractive error in the study eye demonstrating more than -8 diopters of myopia; for subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye can not exceed -8 diopters of myopia
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
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2005-005921-73-NL |
| CCMO | NL11296.018.06 |