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

Primary Purpose

Vitreomacular Attachment, Vitreomacular Traction, Vitreomacular Adhesion

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
36% Resolvine Intravitreal Injection
9% Resolvine Intravitreal Injection
Sponsored by
Jeffrey S Heier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreomacular Attachment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retina-Vitreous Associates Medical Group
  • Ophthalmic Consultants of Boston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

36% Resolvine

9% Resolvine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 14, 2013
Last Updated
March 29, 2016
Sponsor
Jeffrey S Heier
Collaborators
Kato Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01966328
Brief Title
A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
Official Title
A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
Study Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jeffrey S Heier
Collaborators
Kato Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreomacular Attachment, Vitreomacular Traction, Vitreomacular Adhesion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
36% Resolvine
Arm Type
Experimental
Arm Description
Patients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
Arm Title
9% Resolvine
Arm Type
Active Comparator
Arm Description
Patients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30
Intervention Type
Drug
Intervention Name(s)
36% Resolvine Intravitreal Injection
Intervention Description
36% Resolvine Intravitreal Injection
Intervention Type
Drug
Intervention Name(s)
9% Resolvine Intravitreal Injection
Intervention Description
9% Resolvine Intravitreal Injection
Primary Outcome Measure Information:
Title
Safety of 36% Resolvine Injection versus 9% Resolvine Injection
Description
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.
Title
Efficacy of 36% Resolvine Injection versus 9% Resolvine Injection
Description
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
Secondary Outcome Measure Information:
Title
Inducement of PVD
Description
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
Title
Improved Eye Function
Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey S Heier, MD
Organizational Affiliation
Ophthalmic Consultants of Boston
Official's Role
Principal Investigator
Facility Information:
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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