Vitreomacular AttachmentPhase 1NCT01966328
A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
A Phase 1 study testing 36% Resolvine Intravitreal Injection and 9% Resolvine Intravitreal Injection in people with Vitreomacular Attachment and Vitreomacular Traction, run by Jeffrey S Heier at 2 sites in United States.
Trial summary
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Attachment, Vitreomacular Traction, Vitreomacular Adhesion
- What is being tested?
- 36% Resolvine Intravitreal Injection and 9% Resolvine Intravitreal Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2013to Oct 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114
About this study
This research is studying the effect that Resolvine injection will have on patients with vitreomacular adhesion.
Read the 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.
- Being tested
- 36% Resolvine Intravitreal Injection, 9% Resolvine Intravitreal Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
36% Resolvine Intravitreal InjectionDrug
36% Resolvine Intravitreal Injection
9% Resolvine Intravitreal InjectionDrug
9% Resolvine Intravitreal Injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: 9% Resolvine Intravitreal Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: After all patients have completed the 6 month follow-up
Secondary outcomes (2)
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.
Measured: 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.
Measured: After all patients have completed the 6 month follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreomacular AttachmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey S Heier
- Sponsor type
- University, hospital or other
- Collaborators
- Kato Pharmaceuticals, Inc.
- Responsible party
- Sponsor-investigator, Jeffrey S Heier, Ophthalmic Consultants of Boston
- Investigators
- Jeffrey S Heier, MD, Principal investigator, Ophthalmic Consultants of Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01966328
- Sponsor's protocol ID
- VMA-001
- Status last verified
- Mar 2016
- First submitted
- 14 Oct 2013
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Efficacy Assessment of Resolvine for Treatment of Vitreomacular Attachment
- ClinicalTrials.gov ID
- NCT01966328
- Acronym / sponsor ID
- VMA-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Jeffrey S HeierUniversity, hospital or other
- Collaborators
- Kato Pharmaceuticals, Inc.
- Study start
- Oct 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 21 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36% Resolvine | Experimental | Drug: 36% Resolvine Intravitreal InjectionPatients in this arm will be given one dose of 36% Resolvine intravitreal injection, with the possibility of a second dose at Day 30 |
| 9% Resolvine | Active comparator | Drug: 9% Resolvine Intravitreal InjectionPatients in this arm will be given one dose of 9% Resolvine intravitreal injection, with the possibility of a second dose at Day 30 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 36% Resolvine Intravitreal Injection36% Resolvine Intravitreal Injection | Drug | 36% Resolvine |
| 9% Resolvine Intravitreal Injection9% Resolvine Intravitreal Injection | Drug | 9% Resolvine |
Primary outcome
Safety of 36% Resolvine Injection versus 9% Resolvine Injection
Time frame: After all patients have completed the 6 month follow-up.
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
Time frame: After all patients have completed the 6 month follow-up
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.
2 secondary outcomes
Inducement of PVD
Time frame: After all patients have completed the 6 month follow-up
Improved Eye Function
Time frame: After all patients have completed the 6 month follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey S Heier, MD principal investigator
Ophthalmic Consultants of Boston
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 36% Resolvine Intravitreal Injection and 9% Resolvine Intravitreal Injection in people with Vitreomacular Attachment and Vitreomacular Traction, run by Jeffrey S Heier at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of 36% Resolvine Injection versus 9% Resolvine Injection (time frame: After all patients have completed the 6 month follow-up.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.