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

NCT ID: NCT01966328

Last Updated: 2016-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-10-31

Brief Summary

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

Detailed Description

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.

Conditions

Vitreomacular Attachment; Vitreomacular Traction; Vitreomacular Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

36% Resolvine

Patients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30

Group Type: EXPERIMENTAL

36% Resolvine Intravitreal Injection

Intervention Type: DRUG

36% Resolvine Intravitreal Injection

9% Resolvine

Patients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30

Group Type: ACTIVE_COMPARATOR

9% Resolvine Intravitreal Injection

Intervention Type: DRUG

9% Resolvine Intravitreal Injection

Interventions

36% Resolvine Intravitreal Injection

36% Resolvine Intravitreal Injection

Intervention Type: DRUG

9% Resolvine Intravitreal Injection

9% Resolvine Intravitreal Injection

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female subjects, 18 years of age or older

2. Willing and able to return for all study visits

3. Willing and able to provide written informed consent

4. Have symptomatic VMA.

5. If both eyes are found to have Anatomic VMA the eye with lower visual acuity will be declared the study eye.

Exclusion Criteria

1. 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)

2. Subjects who have monocular vision or contralateral vision of 20/400 or worse BCVA in the non-study eye

3. Subjects with a history of retinal detachment or tear in the study eye

4. Subjects who have PVD in the study eye at Baseline (Grade III or greater PVD by B-scan)

5. 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.

6. Subjects with an aphakic study eye or if pseudophakic, cataract extraction surgery less than 6 months prior to study enrollment

7. Subjects with a history of ocular trauma of any type in the study eye

8. Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye per the investigator's judgment

9. Subjects that have undergone any previous vitrectomy (either anterior or pars plana vitrectomy) in the study eye

10. Subjects with a history of cataract surgery complications in the study eye

11. Subjects that have undergone previous photocoagulation of the retina in the study eye

12. Subjects with any evidence or history of either nonproliferative or proliferative diabetic retinopathy (NPDR) or (PDR) in the study eye

13. Subjects with an anticipated need for cataract extraction in the study eye within the next 6 months

14. Subjects with congenital eye malformations

15. Subjects with recurrent uveitis or history of uveitis in either eye

16. Subjects with ongoing ocular infection or inflammation in the study eye

17. Subjects who are pregnant or nursing. Subjects of child bearing ages will undergo pregnancy testing.

18. Subjects that are currently participating in any other investigational research study

19. Subjects who are too ill to be likely to complete the entire study

20. 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

21. Subjects who are uncontrolled diabetics (HbA1/C > 10%) with significant morphological pathology at the time of enrollment

22. Subjects with macular holes Stage 2 or greater as determined by OCT, B-scan ultrasound and clinical examination

23. Subjects with epiretinal membrane (ERM) at the area of attachment as determined by OCT

24. Subjects that have received other intravitreal injection therapy within thirty (30) days of treatment with Resolvine®

25. Subjects that have received more than one Jetrea injection in the study eye

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kato Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: collaborator

Jeffrey S Heier

OTHER

Sponsor Role: lead

Responsible Party

Jeffrey S Heier

Sponsor-Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Jeffrey S Heier, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of Boston

Locations

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

VMA-001

Identifier Type: -

Identifier Source: org_study_id