Ocriplasmin for Vitreomacular Traction/Symptomatic Vitreomacular Adhesion
Study Details
Study Description
Brief Summary
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA™®) over a 6-month period.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ocriplasmin Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection |
Drug: Ocriplasmin 0.125 mg in a 0.1 mL volume
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation [Day 28]
Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis.
Secondary Outcome Measures
- Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180 [Baseline (Day 0), Day 7, Day 28, Day 90, Day 180]
BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline) [Day 7, Day 28, Day 90, Day 180]
The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. One eye (study eye) contributed to the analysis.
- Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 [Baseline (Day 0), Day 7, Day 90, Day 180]
As described in Primary Outcome Measure
- Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 [Day 180]
Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. One eye (study eye) contributed to the analysis.
- Change From Baseline in Central Foveal Thickness at Days 28 and 180 [Baseline (Day 0), Day 28, Day 180]
Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of VMT/sVMA, with evidence of focal VMT visible on Spectral Domain - Optical Coherence Tomography (SD-OCT).
-
Read, sign, and date an Institutional Review Board/Ethics Committee-approved informed consent form.
-
Willing and able to attend all study visits.
-
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria:
-
Women of childbearing potential if pregnant, test positive on a urine pregnancy test, intend to become pregnant during the study period, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
-
Hypersensitivity to ocriplasmin or any of the JETREA™® excipients.
-
Active or suspected intraocular or periocular infection in either eye.
-
Participation in any interventional clinical trial within 30 days prior to baseline.
-
Presence of epiretinal membrane (ERM) over the macula at baseline in the study eye.
-
Broad VMT/VMA > 1500 microns at baseline in the study eye.
-
History of vitrectomy in the study eye.
-
History of laser photocoagulation to the macula in the study eye.
-
Any relevant concomitant ocular condition in the study eye that, in the opinion of the Investigator, could be expected to worsen or require surgical intervention during the study period.
-
Macular hole of > 400 microns diameter in the study eye.
-
High myopia in the study eye.
-
Pseudo-exfoliation, Marfan's syndrome, phacodonesis, or any other finding in the study eye that, in the Investigator's opinion, suggests lens/zonular instability.
-
Aphakia in the study eye.
-
History of retinal detachment in the study eye.
-
Recent ocular surgery or ocular injection in the study eye within the past 90 days (including laser therapy).
-
Proliferative diabetic retinopathy or ischemic retinopathies in the study eye.
-
Retinal vein occlusions in the study eye.
-
Exudative age-related macular degeneration (AMD) in the study eye.
-
Vitreous hemorrhage in the study eye.
-
Other protocol-specified exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Laboratories (Australia) for Trial Locations | New South Wales | Australia | 2113 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Associate Dir of Operations, Ophthalmology, GMA, Alcon, A Novartis Division
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RTA255-P001
Study Results
Participant Flow
| Recruitment Details | Subjects were recruited from 9 sites located in Australia and 1 site located in New Zealand. |
|---|---|
| Pre-assignment Detail | Of the 62 enrolled, 10 subjects were exited as screen failures prior to initiation of treatment. This reporting group includes all eligible subjects (52). |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal (IVT) injection |
| Period Title: Overall Study | |
| STARTED | 52 |
| COMPLETED | 50 |
| NOT COMPLETED | 2 |
Baseline Characteristics
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Overall Participants | 52 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
74.5
(7.0)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
39
75%
|
| Male |
13
25%
|
Outcome Measures
| Title | Percentage of Subjects With Non-surgical Resolution of Focal VMT/sVMA at Day 28, as Determined by Central Reading Center (CRC) Spectral Domain Optical Coherence Tomography (SD-OCT) Evaluation |
|---|---|
| Description | Vitreous separation was assessed, by SD-OCT according to CRC OCT image reading, into 1 of 12 categories, where the targeted status of VMA resolution was 7=Vitreous attached only at optic nerve (ON) or at ON and elsewhere, but not attached in macular, 9=Vitreous visible with complete separation and no attachment, and 10=No visible vitreous separation, which needed to be reached without prior vitrectomy. The assessment of resolution of VMT/sVMA was based upon the anatomical resolution of VMA only, i.e. no resolution of the related symptoms was considered. One eye (study eye) contributed to the analysis. |
| Time Frame | Day 28 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Missing data imputed using the last observation carried forward (LOCF) method. Subjects who had vitrectomy after VMA resolution are considered as 'no VMA resolution' after timepoint of vitrectomy. |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 52 |
| Number [percentage of subjects] |
26.9
|
| Title | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Distance at Days 7, 28, 90, and 180 |
|---|---|
| Description | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) testing. BCVA was determined as follows: if tested at 4 meters, BCVA=the number of letters read correctly at 4 meters+30; if tested at 1 meter, BCVA=the number of letters read correctly at 1 meter, with 83-84 representing normal vision. BCVA change was defined as a change in letters read from the baseline assessment. A positive change value indicates improvement. One eye (study eye) contributed to the analysis. |
| Time Frame | Baseline (Day 0), Day 7, Day 28, Day 90, Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Missing data imputed using the LOCF method. BCVA values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy. |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 52 |
| Baseline (BL) |
70.6
(10.62)
|
| Change from BL at Day 7 |
-1.8
(7.09)
|
| Change from BL at Day 28 |
1.0
(7.67)
|
| Change from BL at Day 90 |
2.1
(8.07)
|
| Change from BL at Day 180 |
3.3
(9.16)
|
| Title | Percentage of Subjects With Closure of Macular Hole (MH), at Days 7, 28, 90, and 180 (if Present at Baseline) |
|---|---|
| Description | The closure of macular hole (a full thickness defect of the retinal tissue involving the anatomical fovea) is defined as a flattened and reattached hole rim along the whole circumference of macular hole. Closure was determined by SD-OCT evaluation and the percentage of subjects tabulated. One eye (study eye) contributed to the analysis. |
| Time Frame | Day 7, Day 28, Day 90, Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| This analysis population includes all subjects in Full Analysis Set with MH at baseline (n=4). Subjects who had vitrectomy after MH closure are considered as 'no MH closure' after the timepoint of vitrectomy. |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 4 |
| Day 7 |
25.0
|
| Day 28 |
50.0
|
| Day 90 |
50.0
|
| Day 180 |
50.0
|
| Title | Percentage of Subjects With Non-surgical Resolution of VMT/sVMA at Days 7, 90, and 180 |
|---|---|
| Description | As described in Primary Outcome Measure |
| Time Frame | Baseline (Day 0), Day 7, Day 90, Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set. Missing data imputed for Days 90 and 180 using the LOCF method. Subjects who had vitrectomy are considered as 'no VMA resolution' after the timepoint of vitrectomy. |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 52 |
| Day 7 |
19.2
|
| Day 90 |
38.5
|
| Day 180 |
40.4
|
| Title | Percentage of Subjects Experiencing Pars Plana Vitrectomy (PPV) at Day 180 |
|---|---|
| Description | Pars plana vitrectomy (the surgical removal of vitreous gel from the eye) was captured in Concomitant Ocular Procedures. One eye (study eye) contributed to the analysis. |
| Time Frame | Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Full Analysis Set |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 52 |
| Number [percentage of subjects] |
7.7
|
| Title | Change From Baseline in Central Foveal Thickness at Days 28 and 180 |
|---|---|
| Description | Central foveal thickness (CFT) was determined by subtracting the measurements in subretinal fluid (SRF) and retinal pigment epithelium (RPE) elevation and/or subretinal hyper-reflective material (SHRM) from the value in total retinal measurement. The change was defined as a change from baseline values of CFT. One eye (study eye) contributed to the analysis. |
| Time Frame | Baseline (Day 0), Day 28, Day 180 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Missing data is imputed using the LOCF method. CFT values after a vitrectomy are imputed with the last non-missing value prior to the vitrectomy. |
| Arm/Group Title | Ocriplasmin |
|---|---|
| Arm/Group Description | Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection |
| Measure Participants | 52 |
| Baseline (BL) |
302.3
(161.23)
|
| Change from BL at Day 28 |
-35.5
(95.53)
|
| Change from BL at Day 180 |
-17.6
(143.63)
|
Adverse Events
| Time Frame | Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 7 months). AEs are reported as pretreatment and treatment-emergent. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment (ie, initiation of treatment with test article) regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from subjects and through observations by the Investigator as outlined in the study protocol. | |||
| Arm/Group Title | Pretreatment | Jetrea | ||
| Arm/Group Description | All subjects who consented to participate in the study prior to initiation of study treatment | Subjects exposed to Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by IVT injection | ||
All Cause Mortality |
||||
| Pretreatment | Jetrea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/52 (0%) | ||
Serious Adverse Events |
||||
| Pretreatment | Jetrea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 5/52 (9.6%) | ||
| Cardiac disorders | ||||
| Atrial fibrillation | 0/62 (0%) | 1/52 (1.9%) | ||
| Eye disorders | ||||
| Macular hole | 0/62 (0%) | 1/52 (1.9%) | ||
| Gastrointestinal disorders | ||||
| Intestinal haemorrhage | 0/62 (0%) | 1/52 (1.9%) | ||
| Infections and infestations | ||||
| Lung infection | 0/62 (0%) | 1/52 (1.9%) | ||
| Injury, poisoning and procedural complications | ||||
| Joint dislocation | 0/62 (0%) | 1/52 (1.9%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Pretreatment | Jetrea | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/62 (1.6%) | 41/52 (78.8%) | ||
| Eye disorders | ||||
| Eye pain | 0/62 (0%) | 4/52 (7.7%) | ||
| Lacrimation increased | 0/62 (0%) | 3/52 (5.8%) | ||
| Metamorphopsia | 0/62 (0%) | 8/52 (15.4%) | ||
| Photopsia | 0/62 (0%) | 27/52 (51.9%) | ||
| Vision blurred | 0/62 (0%) | 12/52 (23.1%) | ||
| Visual acuity reduced | 0/62 (0%) | 11/52 (21.2%) | ||
| Visual impairment | 0/62 (0%) | 9/52 (17.3%) | ||
| Vitreous floaters | 1/62 (1.6%) | 6/52 (11.5%) | ||
| Infections and infestations | ||||
| Influenza | 0/62 (0%) | 3/52 (5.8%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
| Name/Title | Worldwide Medical Affairs Director, GMA Retina Lucentis |
|---|---|
| Organization | Alcon, A Novartis Division |
| Phone | 1-888-451-3937 |
| alcon.medinfo@alcon.com |
- RTA255-P001