Age Related Macular Degeneration
Conditions
Brief summary
This is a single-masked study to compare intravitreally administered 0.5 mg ranibizumab to 2.0 mg ranibizumab in subjects who manifest persistent or recurrent macular fluid less than 30 days following treatment with intravitreal anti-VEGF therapy. Patients will be masked to their treatment assignment. The study duration is anticipated to be 12 months and will enroll 30 subjects . Patients will be randomized 2:1 to either 2.0 mg ranibizumab or 0.5mg ranibizumab.
Interventions
DRUGRanibizumab
2.0 mg
Sponsors
Genentech, Inc.
Vitreous -Retina- Macula Consultants of New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Subjects will be eligible if the following criteria are met: * Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 50 years * Subfoveal neovascularization secondary to AMD * Best corrected visual acuity in the study eye between 20/30 to 20/400 using an ETDRS chart * Documentation of the presence of subretinal fluid and/or cystoid macular edema on SD-OCT less than 30 days following at least six months of anti-VEGF therapy * Presence of fibrosis, hemorrhage, or other hypofluorescent lesions should not obscure greater than 50% of the CNV lesion
Exclusion criteria
Subjects who meet any of the following criteria will be excluded from this study: * Pregnancy (positive pregnancy test) or lactation * Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch. * Participation in another simultaneous medical investigation or trial * Prior treatment with anti-VEGF therapy in the study eye within 30 days of BSL * Prior treatment with triamcinolone in the study eye within 6 months of BSL. * Prior treatment with dexamethasone in the study eye within 30 days prior to BSL * Past treatment with PDT or thermal laser in the study eye * Intraocular surgery (including cataract surgery) in the study eye within 2 months preceding BSL * History of vitrectomy surgery, submacular surgery, or other surgical intervention for AMD in the study eye * Active intraocular inflammation (grade trace or above) in the study eye * Current vitreous hemorrhage in the study eye * History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye * Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye * Uncontrolled glaucoma in the study eye (defined as IOP ≥ 30 mmHg despite treatment with anti-glaucoma medication) * History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment. * History of allergy to fluorescein, not amenable to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Change in Visual Acuity (VA) From Baseline at Month 6 | Baseline and 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Visual Acuity (VA) From Baseline at Month 12 | one year | * Mean change in Visual Acuity (VA) from Baseline at Month 12 * Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12 * Mean change in leakage as determined by FA at Months 6 and 12 * Mean number of ranibizumab injections at Months 6 and 12 * Mean time to first re-treatment following the initial 3 monthly loading doses * Mean duration of fluid-free interval * Safety and tolerability of 2.0mg using the incidence and severity of adverse events |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lucentis 2.0 mg Lucentis (ranibizumab) 2.0 mg | 7 |
| Lucentis 0.5 mg Lucentis (ranibizumab) 0.5 mg | 2 |
| Total | 9 |
Baseline characteristics
| Characteristic | Lucentis 2.0 mg | Lucentis 0.5 mg | Total |
|---|---|---|---|
| Age, Customized | 80.1 years STANDARD_DEVIATION 5.4 | 88.0 years STANDARD_DEVIATION 0 | 82.0 years STANDARD_DEVIATION 5.8 |
| Sex: Female, Male Female | 5 Participants | 1 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 1 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 9 | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 |
Outcome results
Primary
Mean Change in Visual Acuity (VA) From Baseline at Month 6
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lucentis 2.0 mg | Mean Change in Visual Acuity (VA) From Baseline at Month 6 | 6.1 ETDRS Letters | Standard Deviation 3.7 |
| Lucentis 0.5 mg | Mean Change in Visual Acuity (VA) From Baseline at Month 6 | 2.0 ETDRS Letters | Standard Deviation 0 |
Secondary
Mean Change in Visual Acuity (VA) From Baseline at Month 12
* Mean change in Visual Acuity (VA) from Baseline at Month 12 * Mean change in central foveal thickness (RPE to ILM) as measured by SD-OCT (Spectralis HRA + OCT (Heidelberg Engineering, Heidelberg, Germany) at Months 6 and 12 * Mean change in leakage as determined by FA at Months 6 and 12 * Mean number of ranibizumab injections at Months 6 and 12 * Mean time to first re-treatment following the initial 3 monthly loading doses * Mean duration of fluid-free interval * Safety and tolerability of 2.0mg using the incidence and severity of adverse events
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lucentis 2.0 mg | Mean Change in Visual Acuity (VA) From Baseline at Month 12 | 4.1 ETDRS Letters | Standard Deviation 4.5 |
| Lucentis 0.5 mg | Mean Change in Visual Acuity (VA) From Baseline at Month 12 | 3.0 ETDRS Letters | Standard Deviation 0 |