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

Vitreomacular Traction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01966328
• Other study ID #: VMA-001
• Status: Active, not recruiting
• Phase: Phase 1
• First received: October 14, 2013
• Last updated: May 21, 2015
• Start date: October 2013

Study information

• Verified date: May 2015
• Source: Ophthalmic Consultants of Boston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitreomacular Adhesion
• Vitreomacular Attachment
• Vitreomacular Traction

Intervention

Drug:
• 36% Resolvine Intravitreal Injection
36% Resolvine Intravitreal Injection
• 9% Resolvine Intravitreal Injection
9% Resolvine Intravitreal Injection

Locations

Country	Name	City	State
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Jeffrey S Heier	Kato Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	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	No
Secondary	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.	After all patients have completed the 6 month follow-up	No
Secondary	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.	After all patients have completed the 6 month follow-up.	No