This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion. The investigators propose that intravitreal injection of Resolvine® 36% will: 1)Result in release of the vitreous adhesion to the macula in subjects with symptomatic vitreomacular attachment (VMA). 2)The Release of the VMA will create a measurable and favorable retinal change. 3) The release of vitreomacular traction may also result in visual acuity improvement within the short time frame of this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
36% Resolvine Intravitreal Injection
9% Resolvine Intravitreal Injection
Retina-Vitreous Associates Medical Group
Beverly Hills, California, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
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.
Time frame: 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.
Time frame: After all patients have completed the 6 month follow-up
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.
Time frame: After all patients have completed the 6 month follow-up
Improved Eye Function
These analyses will assess a parameter of improved eye function as calculated by either the reduction in the retinal thickness of at least 10% over baseline at Day 0 as quantified by OCT, or an improvement in visual acuity of more than 10% over baseline at day 0 as quantified by ETDRS.
Time frame: After all patients have completed the 6 month follow-up.
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