Fibrovascular Pigment Epithelial Detachment Clinical Trial
Official title:
This is an Open Label Study to Evaluate the Efficacy of Intravitreal Aflibercept Injection 2mg in Patients With a Persistent FVPED Despite at Least 6 Consecutive Injections With Ranibizumab 0.5 mg
| Verified date | May 2018 |
| Source | Vitreous -Retina- Macula Consultants of New York |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is an open label study to evaluate the efficacy of intravitreal aflibercept injection 2mg in patients with a persistent FVPED despite at least 6 consecutive injections with ranibizumab 0.5 mg.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | October 2012 |
| Est. primary completion date | October 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
- Ability to provide written informed consent and comply with study assessments for the
full duration of the study - Age > 50 years - Subfoveal FVPED assessed using clinical examination and OCT - Best corrected visual acuity in the study eye between 20 and 85 letters on the ETDRS chart (20/30 to 20/800 Snellen equivalent) - Prior treatment with at least 6 consecutive injections with ranibizumab 0.5 mg prior to the baseline visit; the last treatment with ranibizumab should not exceed 45 days from the baseline visit. Exclusion Criteria: - Pregnancy (positive pregnancy test) or lactation - Participation in another simultaneous medical investigation or trial - Prior treatment with ranibizumab therapy in the study eye within 30 days of baseline - Prior treatment with PDT in the study eye - Prior intravitreal injection of a corticosteroid (triamcinolone, dexamethasone) within 120 days from baseline. - Presence of significant subfoveal fibrosis or atrophy determined using SDOCT, fluorescein angiography and clinical examination. - Presence of fibrous or fibrocellular material occupying more than 50% of the sub-RPE space; assessed using EDI OCT - Presence of a RPE tear, determined by clinical examination, FA, FAF and OCT - Intraocular surgery (including cataract surgery) in the study eye within 90 days preceding baseline - History of pars plana vitrectomy, submacular surgery or any other surgical intervention for vitreo-retinal diseases in the study eye - Presence of or previous history of diabetic macular edema or proliferative diabetic retinopathy. - History of uveitis in the study eye - Current vitreous hemorrhage in the study eye - History of rhegmatogenous retinal detachment, macular hole and lamellar hole and 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) - In patients with glaucoma, advanced field loss; mean deviation on threshold visual field of more than 12 decibels. - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Vitreous Retina Macula Consultants of New York | New York | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Vitreous -Retina- Macula Consultants of New York | Regeneron Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | Using the Heidelberg software, subfoveal subretinal fluid (distance between the IS/OS line and the RPE line on SDOCT) | 24 weeks is the primary end point of the study | |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | Measure of retinal volume (distance between the ILM and RPE outer margin on SDOCT) | 24 weeks is the primary end point of the study | |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | Measure of PED height (distance between ILM and Bruchs membrane (if visible) or the horizontal line where the RPE should be present if it was not elevated) | 24 weeks is the primary end point of the study | |
| Primary | Change in retinal anatomy (size of FVPED, sub-retinal fluid and retinal volume) from baseline; measured using Spectralis OCT (Heidelberg Engineering, Germany) | Measure of maximal diameter of the PED (measured as the point from where the RPE detachment begins to where it ends) will be measured. | 24 weeks is the primary end point of the study | |
| Secondary | Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS visual refraction at 4 meters. | Proportion of patients losing = 15 ETDRS letters compared to baseline. Proportion of patients gaining = 5 ETDRS letters compared to baseline. |
24 weeks is the primary end point of the study | |
| Secondary | Mean change in best corrected visual acuity (BCVA) from baseline; measured by ETDRS | Measure the Change in sub-RPE tissue characteristics from baseline; determined using EDI-OCT on the Spectralis OCT | 24 weeks is the primary end point of the study |