A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment

NCT01966328 | Completed Phase 1

• 1 other identifier: VMA-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 2

Brief Summary

This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.

Conditions

Vitreomacular Attachment; Vitreomacular Traction; Vitreomacular Adhesion

Outcome Measures

Primary Outcomes (2)

• 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 (2)

• Inducement of PVD

  After all patients have completed the 6 month follow-up

• Improved Eye Function

  After all patients have completed the 6 month follow-up.

Study Arms (2)

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

Interventions

36% Resolvine Intravitreal Injection DRUG

36% Resolvine Intravitreal Injection

36% Resolvine

9% Resolvine Intravitreal Injection DRUG

9% Resolvine Intravitreal Injection

9% Resolvine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Jeffrey S Heier: lead
• Kato Pharmaceuticals, Inc.: collaborator

Study Sites (2)

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Study Officials

• Jeffrey S Heier, MD

  Ophthalmic Consultants of Boston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

US (2)