Age-Related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
Conditions
Brief summary
This study was conducted because the FDA requested clinical information on potential effects of intravitreal injections of Macugen (pegaptanib sodium injection) on the corneal endothelium from a 1-year (minimum) post-approval clinical study to support that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Interventions
DRUGpegaptanib sodium injection
0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
Sponsors
Bausch & Lomb Incorporated
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects of either gender aged \> or = to 50 years diagnosed with subfoveal neovascular Age-Related Macular Degeneration, Diabetic Macular Edema, or Retinal Vein Occlusion. 2. Best corrected visual acuity in the study eye between 85 and 20 ETDRS letters or between 20/20 and 20/400 using a Snellen chart. 3. Women must be using two forms of effective contraception, be post-menopausal for at least 12 months prior to study entry, or surgically sterile; if of child-bearing potential, a urine pregnancy test must be performed within 7 days prior to the first injection with a negative result. If the test is positive, a serum test must be done to confirm. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. 4. Provide written informed consent. 5. Ability to return for all study visits.
Exclusion criteria
Subjects will not be eligible for the study if subjects cannot attend all study-required visits, or if any of the following criteria are present 1. Unilateral ocular blunt trauma within one year of enrollment and no greater than 5% difference in central endothelial cell density between the 2 eyes. 2. intraocular surgery (cataract surgery and surgery for glaucoma without tube shunt or mini-shunt) within one year of enrollment. 3. Anterior segment laser surgery (laser trabeculoplasty) performed within one year of enrollment. 4. Glaucoma tube-shunt surgery 5. Previous history of corneal transplant in the study or non-study eye 6. Presence of vitreous macular traction 7. Previous therapeutic radiation in the region of the study eye 8. Any treatment with an investigational agent in the past 30 days for any condition 9. Known serious allergies to the components of pegaptanib sodium formulation Any of the following underlying diseases including:1. History or evidence of severe cardiac disease(e.g. NYHA Functional Class III or IV - see Appendix 2), clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within 6 months, ventricular tachyarrhythmias requiring ongoing treatment 7. History or evidence of clinically significant peripheral vascular disease, such as intermittent claudication or prior amputation 8. History or evidence of clinically significant impaired renal or hepatic function 8. Stroke (within 12 months of study entry) 9. Any major surgical procedure within one month of study entry 10. Significant media opacities, including cataract, which might interfere with visual acuity, assessment of toxicity. Subjects should not be entered if there is likelihood that they will require cataract or glaucoma surgery in either eye during the study treatment and follow-up period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Endothelial Cell Density | Baseline, Week 54 | The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Injections of Macugen pegaptanib sodium injection: 0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks | 131 |
| Total | 131 |
Baseline characteristics
| Characteristic | Intravitreal Injections of Macugen |
|---|---|
| Age, Continuous | 71.0 years STANDARD_DEVIATION 10.17 |
| Designated eye Left eye | 62 Participants |
| Designated eye Right eye | 69 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 40 Participants |
| Race (NIH/OMB) White | 81 Participants |
| Sex: Female, Male Female | 76 Participants |
| Sex: Female, Male Male | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 131 |
| other Total, other adverse events | 19 / 131 |
| serious Total, serious adverse events | 12 / 131 |
Outcome results
Primary
Change From Baseline in Mean Endothelial Cell Density
The effect on the corneal endothelium will be assessed by specular microscopy, by assessing mean cell density change from baseline. This is to evaluate that there are no adverse effects on the corneal endothelium following intravitreal injections of Macugen.
Time frame: Baseline, Week 54
Population: Participants with cell density assessments at both baseline and Week 54.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal Injections of Macugen | Change From Baseline in Mean Endothelial Cell Density | -35.86 cells/millimeter squared | Standard Deviation 175.544 |