A Safety and Efficacy Assessment of Resolvine for Treatme... | NCT01966328

Status Module

Name	Class
Kato Pharmaceuticals, Inc.	INDUSTRY

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
36% Resolvine	Experimental	Patients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30	Drug: 36% Resolvine Intravitreal Injection
9% Resolvine	Active Comparator	Patients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30	Drug: 9% Resolvine Intravitreal Injection

Name	Type	Description	Arm Group Labels	Other Names
36% Resolvine Intravitreal Injection	Drug	36% Resolvine Intravitreal Injection	36% Resolvine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety of 36% Resolvine Injection versus 9% Resolvine Injection	The primary objective of this study is to evaluate the safety of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Cumulative adverse event rates for each arm will be evaluated.	After all patients have completed the 6 month follow-up.
Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection	The primary objective of this study is to evaluate the efficacy of an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, in comparison to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, in subjects with VMA. Efficacy will be measured by the percent of patients whose VMA has released after treatment.	After all patients have completed the 6 month follow-up

Secondary Outcomes

Measure	Description	Time Frame
Inducement of PVD	These analyses will compare the efficacy an active arm treated with Resolvine® 36%, which may contain up to two 100-microliter intravitreal injections, to a control arm treated with Resolvine 9%, which may contain up to two 100-microliter injections, to assess inducement of a more extensive PVD over the study period as demonstrated by Trese Grade III or higher B-Scan Ultrasound and OCT.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female subjects, 18 years of age or older
Willing and able to return for all study visits
Willing and able to provide written informed consent
Have symptomatic VMA.
If both eyes are found to have Anatomic VMA the eye with lower visual acuity will be declared the study eye.

Exclusion Criteria:

Subjects with high myopia in the study eye (axial length greater than or equal to 26.0 millimeters by ultrasound or spherical equivalent at the spectacle plane greater than -8.0 diopters)
Subjects who have monocular vision or contralateral vision of 20/400 or worse BCVA in the non-study eye
Subjects with a history of retinal detachment or tear in the study eye
Subjects who have PVD in the study eye at Baseline (Grade III or greater PVD by B-scan)
Subjects with unstable IOP (i.e. > 30 mmHg in the past six months) or IOP of > 21 mm Hg at enrollment, under medical control. Subjects may be on topical medications to control their IOP but may not stop or start a prostaglandin type or epinephrine based drug during the study.
Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment
Subjects with a history of ocular trauma of any type in the study eye
Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment
Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy) in the study eye
Subjects with a history of cataract surgery complications in the study eye
Subjects that have undergone previous photocoagulation of the retina in the study eye
Subjects with any evidence or history of either nonproliferative or proliferative diabetic retinopathy (NPDR) or (PDR) in the study eye
Subjects with an anticipated need for cataract extraction in the study eye within the next 6 months
Subjects with congenital eye malformations
Subjects with recurrent uveitis or history of uveitis in either eye
Subjects with ongoing ocular infection or inflammation in the study eye
Subjects who are pregnant or nursing. Subjects of child bearing ages will undergo pregnancy testing.
Subjects that are currently participating in any other investigational research study
Subjects who are too ill to be likely to complete the entire study
Subjects who have undergone major surgery within the last 6 months (systemic or ocular) or who are likely to require major surgery in the upcoming 6 months
Subjects who are uncontrolled diabetics (HbA1/C > 10%) with significant morphological pathology at the time of enrollment
Subjects with macular holes Stage 2 or greater as determined by OCT, B-scan ultrasound and clinical examination
Subjects with epiretinal membrane (ERM) at the area of attachment as determined by OCT
Subjects that have received other intravitreal injection therapy within thirty (30) days of treatment with Resolvine®
Subjects that have received more than one Jetrea injection in the study eye

Facility	Status	City	State	ZIP	Country	Contacts
Retina-Vitreous Associates Medical Group		Beverly Hills	California	90211	United States
Ophthalmic Consultants of Boston