Exudative Age-Related Macular Degeneration, Focal Vitreomacular Adhesion
Conditions
Keywords
AMD
Brief summary
This study will evaluate the safety and efficacy of Ocriplasmin intravitreal injection, in subjects diagnosed with exudative AMD with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal ocriplasmin may offer physicians a safe agent for pharmacologic vitreolysis and nonsurgical resolution of focal vitreomacular adhesion in AMD subjects where this adhesion may be causally associated with worse prognosis).
Interventions
DRUGOcriplasmin
ocriplasmin intravitreal injection (125 µg)
DRUGSham injection
Sham injection
Sponsors
ThromboGenics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged \> 50 2. Presence of focal vitreomacular adhesion measured by Optical Coherence Tomography (OCT). 3. Diagnosis of active primary or recurrent subfoveal CNV secondary to AMD, including those with predominantly classic, minimally classic or occult lesions with no classic component. 4. The total area of Choroidal Neovascularization (CNV) (including both classic and occult components) encompassed within the lesion must be \> 50% of the total lesion area 5. The total lesion area must be \< 12 disc areas 6. Subjects who have previously received at least three antiangiogenic injections(Lucentis® or Avastin®) in the study eye. 7. Subjects with visual acuity of 20/32 to 20/200 in the study eye 8. Written informed consent obtained from the subject prior to inclusion in the study
Exclusion criteria
1. Evidence of complete macular Posterior Vitreous Detachment (PVD) in the study eye on biomicroscopy, B-scan ultrasound or OCT prior to planned study drug injection 2. Subjects with vitreous haemorrhage which precludes either of the following: visualization of the posterior pole by visual inspection or adequate assessment of the macula by either OCT and/or fluorescein angiography in the study eye or other opacities precluding visualisation of the fundus. 3. Subjects who have previously received more than 9 antiangiogenic agent injections (whether Lucentis® or Avastin® or other anti-angiogenic agent) in the study eye 4. Subjects with history of rhegmatogenous retinal detachment or proliferative vitreoretinopathy (PVR) in the study eye 5. Subjects with high myopia (\> 8D) or aphakia in the study eye 6. Subjects who have had ocular surgery in the study eye in the prior three months 7. Subjects who have had a vitrectomy in the study eye at any time.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 | Day 28 | The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation |
Countries
Belgium, France, Germany, Italy, United Kingdom, United States
Participant flow
Recruitment details
First subject was enrolled on 29 Jan 2010 and last subject completed the study on 06 Dec 2012
Participants by arm
| Arm | Count |
|---|---|
| Ocriplasmin Intravitreal injection (125 µg) | 74 |
| Sham Sham injection | 25 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Ocriplasmin | Sham | Total |
|---|---|---|---|
| Age, Continuous | 74.5 years STANDARD_DEVIATION 8.13 | 74.7 years STANDARD_DEVIATION 7.16 | 74.6 years STANDARD_DEVIATION 7.86 |
| Sex: Female, Male Female | 39 Participants | 15 Participants | 54 Participants |
| Sex: Female, Male Male | 35 Participants | 10 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 33 / 75 | 11 / 25 |
| serious Total, serious adverse events | 18 / 75 | 2 / 25 |
Outcome results
Primary
Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28
The VMA release was determined by masked Central Reading Center Optical Coherence Tomography (OCT) evaluation
Time frame: Day 28
Population: The Full Analysis Set (FAS) was the primary data set for efficacy analysis. Data that were missing for any reason were imputed using the Last Observation Carried Forward (LOCF) method.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ocriplasmin | Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 | 24.3 percentage of subjects |
| Sham | Proportion of Subjects With Focal Vitreomacular Adhesion (VMA) Release by Day 28 | 12.0 percentage of subjects |
p-value: 0.26295% CI: [-3.7, 28.4]Fisher Exact