AMD (With Persistent or Recurrent Fluid Despite Monthly Intravitreal Anti-VEGF Therapy)
Conditions
Brief summary
This is an open label study to evaluate intravitreally administered 2.0 mg intravitreal aflibercept injection in patients who have been previously treated for AMD and have persistent or recurrent fluid despite monthly intravitreal anti-VEGF therapy.
Interventions
DRUGAlfilbercept
All patients will receive 2.0 mg intravitreal aflibercept injection.
Sponsors
Vitreous -Retina- Macula Consultants of New York
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and comply with study assessments for the full duration of the study * Age \> 50 years * Choroidal neovascularization secondary to AMD * Best corrected visual acuity in the study eye between 20/25 to 20/400 using an ETDRS chart * Documentation of presence of subretinal fluid and/or cystoid macular edema on SD-OCT following at least four anti-VEGF treatments within six months before enrollment and a maximum of 5 years of years of treatment for neovascular AMD * Documentation of presence of subretinal fluid and/or cystoid macular edema less than 30 days since last treatment
Exclusion criteria
* 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 PDT within the past 3 months or more than 4 prior PDT treatments. * Presence of significant subfoveal fibrosis or atrophy. * Prior treatment with intravitreal aflibercept injection * 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 * 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 * Ocular or periocular infection * Active severe intraocular inflammation * 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, ICG or iodine, not amenable to treatment * Known hypersensitivity to aflibercept or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients With no Fluid on OCT at Week 24 | 24 week | No primary outcome data can be found or provided. |
| Mean Change in Visual Acuity From Baseline to Week 16 | Baseline to Week 16 | Visual acuity was documented via BCVA at every study visit. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16 | Baseline and week 16 | OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan. |
| Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16 | Baseline and 16 weeks | OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intravitreal Aflibercept All eligible patients will receive intravitreal aflibercept injection (2.0mg) every 4 weeks (monthly) for the first 12 weeks (3 months), followed by 2 mg once every 8 weeks (2 months) through Week 24. Patients can be dosed as frequently as 2 mg every 4 weeks (monthly) upon investigator discretion.
Alfilbercept: All patients will receive 2.0 mg intravitreal aflibercept injection. | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Intravitreal Aflibercept |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 8 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Age, Continuous | 74 years |
| EDTRS Visual Acuity Score | 63 Letters |
| First Prescription for Choroidial NeoVascularization | 18.5 Months |
| Lesion Type: ( Fluroscien Angiogram and Occult CNV only | 4 Participants |
| Lesion Type: ( Fluroscien Angiogram and Occult CNV with CSC features | 2 Participants |
| Lesion Type: ( Fluroscien Angiogram and Occult CNV with PCV features | 3 Participants |
| Region of Enrollment United States | 9 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 9 |
| other Total, other adverse events | 3 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Mean Change in Visual Acuity From Baseline to Week 16
Visual acuity was documented via BCVA at every study visit.
Time frame: Baseline to Week 16
Population: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intravitreal Aflibercept | Mean Change in Visual Acuity From Baseline to Week 16 | 4.2 letters | Standard Deviation 6.3 |
Primary
Proportion of Patients With no Fluid on OCT at Week 24
No primary outcome data can be found or provided.
Time frame: 24 week
Population: Patients analyzed is zero due to no outcome data was collected at week 24 due to early termination of the clinical study.
Secondary
Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Time frame: Baseline and week 16
Population: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravitreal Aflibercept | Mean Change in OCT Central Retinal Lesion Thickness From Baseline to Week 16 | -45 Microns |
Secondary
Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16
OCT is performed on the Spectralis spectral domain OCT machine (Heidelberg Engineering, Germany). The OCT is centered on the fovea. The OCT examination will use the 19 scan mode on the Spectralis averaging at least 25 images per scan. Follow-up visits will use the follow-up protocol on the Spectralis , automatically placing follow-up scans in precisely the same location as the baseline scan.
Time frame: Baseline and 16 weeks
Population: The average age of enrollment is 74 years old with first treatment for CNV at 18.5 months.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intravitreal Aflibercept | Mean Change in OCT Greatest Height of Pigment Epithelial Detachment From Baseline to Week 16 | -90 microns |