Impact of Intravitreal Aflibercept Injections on Capillar... | NCT01724554

NCT01724554

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Every Month Treatment	Experimental	Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the 12 month duration of the study.	Drug: Intravitreal Aflibercept Injection
Every Month, then Every Other Month	Experimental	Patients will receive Intravitreal Aflibercept Injection (IAI) every month for the first 6 months, then every other month for the next 6 months. Retreatment criteria will allow for patients to be treated every month in the second 6 months if needed.	Drug: Intravitreal Aflibercept Injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intravitreal Aflibercept Injection	Drug	Aflibercept administered to the eye intravitreally either every month or every other month.	Every Month Treatment Every Month, then Every Other Month

Measure	Description	Time Frame
Mean Change in Capillary Non-Perfusion	To determine mean change in the presence and amount of capillary non-perfusion as measured by wide-angle angiography using Optos 200Tx system at Baseline, Month 3, Month 6, and Month 12.	12 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosis of one or more of the following:

Proliferative retinopathy (PDR) Macular edema secondary to CRVO Proliferative disease secondary to CRVO (anterior segment or posterior segment neovascularization).
Be in need of IAI treatment, whether previously treated or treatment-naïve.
Age > 18 years.

Exclusion Criteria:

Subjects with macular edema secondary to diabetic retinopathy without concomitant proliferative diabetic retinopathy.
Subjects with cataract or other media opacities impairing adequate visualization of the retina to the extent that good quality images are impossible.
Presence of any substantial ocular disease (other than diabetic retinopathy or central retinal vein occlusion) that may compromise vision in the study eye and /or confound interpretation of the data; e.g. substantial cataracts, advanced glaucoma, optic neuritis, optic neuropathy or atrophy, marked macular atrophy, history of retinal detachment, uveitis, viral or other forms of chorioretinitis, etc.
Active intraocular inflammation (grade trace or above) in the study eye, or history of idiopathic or autoimmune-associated uveitis in either eye.
Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥ 25 mmHg despite treatment with anti-glaucoma medication).
History of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye.
Participation in a study of an investigational drug or device within 30 days prior to potential enrollment into the study.
Intraocular surgery (including cataract surgery) in the study eye within 60 days preceding baseline.
History of vitrectomy surgery in the study eye.
Subjects with 12 or more anti-VEGF injections within 24 months prior to Screening.
Subjects who received anti-VEGF therapy within 30 days of Screening or received steroid or laser therapy within 90 days of Screening.
Subjects allergic to fluorescein, povidone iodine (Betadyne) or aflibercept
Pregnant or breast-feeding women.

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis