The primary objective of the study is to evaluate the safety and efficacy of Anecortave Acetate Depot (3, 15 or 30 mg) when administered by AJD for treatment of elevated IOP following intravitreal steroid therapy.
ID
Source
Brief title
Condition
- Eye disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary efficacy endpoint will be the mean change in IOP (mmHg) from
baseline to Week 4. Comparisons between the different treatment groups (3 mg,
15 mg and 3O mg) and placebo will be made.
Secondary outcome
Secondary parameters will include the time to treatment failure and the
pencentage of patients declared to be treatment failures.
A target IOP will be established by the investigator. Patients for whom the
IOP in the study eye exceeds the target IOP at Week 4, will come for an
additional IOP measurement one week later. In case the target IOP is still
exceeded, the patient is considered a treatment failure.
Background summary
locally administered glucocorticoids are commonly used to treat noninfectious
inflammation of the eye. Glucocorticoids have the ability to suppress the
inflammatory response including cellular infiltration, redness and swelling.
Intravitreal injection is becoming more frequently employed for patients with
macular edema. This type of therapy has undesirable side effects however,
including the tendency to raise intraocular pressure (IOP) in certain
individuals. Depending on the potency of the steroid, IOP elevation can develop
within a few weeks or in months. Between 30 to 40% of the general population
responds with moderate to severe increases of IOP when treated with
intravitreal steroids (like triamcinolone acetonide). This increase requires a
treatment with topical ocular hypotensive therapy. If this therapy is not
adequate, surgery is required. Anecortave acetate, administered as a anterior
juxtascleral depot (AJD) may provide an alternative to these approaches.
Anecortave acetate belongs to a unique class of drugs, cortisenes, which have
IOP lowering ability as well as angiostatic activity. The IOP lowering
activity is believed to be due to the normalization of glucocorticoid-induced
changes in the trabecular meshwork, thus increasing aqueous humor outflow.
Study objective
The primary objective of the study is to evaluate the safety and efficacy of
Anecortave Acetate Depot (3, 15 or 30 mg) when administered by AJD for
treatment of elevated IOP following intravitreal steroid therapy.
Study design
This study is a randomized, controlled, double-masked study in which three
treatment groups are compared with placebo.
During the baseline exam, a complete ophthalmic exam will be performed and the
investigator will establish the target IOP, which the patient should meet
following administration of Anecortave Acetate. During the study, the study
eye will be frequently checked and in case the target IOP is not met at Week 4,
the patient is considered as a treatment failure and additional hypotensive
therapy will be started.
Intervention
Every patient who complies with the in- and exclusion criteria, will get one
injection of Anecortave Acetate (3, 15 or 30 mg or placebo) via the AJD
procedure.
Study burden and risks
A burden to the patients can be the frequent follow up visits (Week 1, Week 2,
Week 4, Week 6, Month 3, Month 4.5 and Month 6).
The following adverse events have been reported in patients who received
Anecortave Acetate via the PJD procedure (posterior juxtascleral depot). The
expectation is that the safety profile will not be different in this study.
The study medication could cause all, some or none of the mentioned complaints:
at the injection site: pain, bleeding, scarring, ; ocular pain, decrease of
vision, feeling of discomfort, itchy eye, red eyes, ptosis of upper eyelid,
swelling of eyelids.
Most of the possible effects above may be caused by the injection itself but
are not serious and none will last. However, these effects may be seen in the
placebo group. Other effects, such as cataract and decreased vision, may also
be due to aging.
Rijksweg 14
2870 Puurs
Belgie
Rijksweg 14
2870 Puurs
Belgie
Listed location countries
Age
Inclusion criteria
patients of either sex and any race/ethnicity, 18 years of age or older.
Patient that have received intravitreal steroid therapy.
Patients between 2 and 8 week (14 to 56 days) post-intravitreal steroid therapy with an IOP of at least 24 mmHg and who have an IOP increase > 10 mmHg relative to their pre-steroid therapy in a single eye.
NOTE: only one eye per patient may be enrolled in the study.
Only patients who satisfy all informed consent requirements may be included in the study.
Patient with at least 30 days of stable dosing of ocular hupotensive medications prior to screening may be included.
Patients using nonprescription and/or prescription topical ophthalmic and/or systemic non-glaucoma medications may be included in the study.
Patients who wear contact lenses will be allowed to participate in the study provided that they are willing to discontinue use during the course of the study.
Exclusion criteria
Patients on intravenous or subcutaneous anticoagulant therapy, or patient on oral anticoagulant therapy and cannot take a 5-day interruption in therapy prior to each injection procedure (with exception of aspirin and antiplatelet therapy).
Patients who are currently on therapy or were on therapy with another investigational agent within 30 days prior to screening.
Patients who are currently on therapy or were on therapy with systemic glucocorticoid medications within 30 days prior to Screening Visit.
Patients who have a known medical history of allergy to the steroid family of drugs.
History of ocular trauma wihin the past six months in the study eye (eye to be treated).
Patient with a history of penetrating glaucoma surgery (i.e. trabeculectomy, valves, etc.) in the study eye.
Patient has had an insertion of scleral buckle in the study eye.
Patients with a cup/disc ratio greater than 0.80 (horizontal or vertical measurement) in either eye.
Any abnormality preventing reliable applanation tonometry of the study eye.
Patients with clinical evidence of scleral thinning seen at the time of external eye examination or at the time of administration.
History or other evidence of severe illness or any other condition which would make the patient, in the opinion of the Investigator, unsuitable for the study.
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 | EUCTR2006-003356-38-NL |
| CCMO | NL14539.091.06 |