Symptomatic Focal Vitreomacular AdhesionPhase 2NCT02153476

A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion

A Phase 2 study testing 2.0mg of ALG-1001 and Balanced Salt Solution in people with Symptomatic Focal Vitreomacular Adhesion, run by Allegro Ophthalmics, LLC at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Symptomatic Focal Vitreomacular Adhesion
What is being tested?: 2.0mg of ALG-1001 and Balanced Salt Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 45 participants
Where: 5 sitesUnited States
Study dates: Feb 2014to Jun 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Symptomatic focal vitreomacular adhesion
Vitreomacular traction syndrome
Stage 1 and 2 macular holes, ≤ 350 µm
BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
BCVA of 20/800 ETDRS or better in the fellow eye
Male or female subjects, 18 years of age or older
Signed Informed Consent

Who cannot join

High myopes > -8.0 D spherical equivalent
History of prior vitrectomy in the study eye
History of photocoagulation to the retina in the study eye
Macular hole in the study eye > 350 µm
Subjects with epiretinal membranes in the study eye
Subjects with broad VMA, defined as VMA of >1500 µm

Show all 12Show fewer

Subjects with proliferative Diabetic Retinopathy (DR), neovascular Age-related Macular Degeneration (AMD), or retinal vascular occlusion in the study eye
Subjects with aphakia in the study eye
Subjects with uncontrolled glaucoma
Subjects with lenticular or zonular instability
Subjects with prior ocular surgery or intravitreal injection in the study eye within 90 days of study enrollment
Pregnant or nursing women

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Austin Retina Associates
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Retina Consultants Houston
Houston, Texas, 77030
California Retina Consultants
Santa Barbara, California, 93103
Center for Retinal and Macular Disease
Winter Haven, Florida, 33880

Other trials in United States

About this study

Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion

Conditions: Symptomatic Focal Vitreomacular Adhesion
Being tested: 2.0mg of ALG-1001, Balanced Salt Solution

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

2.0mg of ALG-1001Drug
Balanced Salt SolutionDrug

Study groups in NCT02153476
Study group	Role	What they receive
2.0mg of ALG-1001	Experimental	2.0mg of ALG-1001 Receives: Drug: 2.0mg of ALG-1001
Intravitreal injection in 0.05cc balanced salt solution.	Placebo comparator	Balanced Salt Solution Receives: Drug: Balanced Salt Solution

What is being measured

The primary outcome is the main question the study is designed to answer.

Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.
Measured: 90 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2014Jun 2015

First posted3 Jun 2014 (estimated)
Study startFeb 2014
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Symptomatic Focal Vitreomacular AdhesionStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02153476
Sponsor's protocol ID: VMA-202
Status last verified: Nov 2018
First submitted: 27 May 2014
Last updated: 19 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Safety And Efficacy Study Of Alg-1001 In Human Subjects With Symptomatic Focal Vitreomacular Adhesion
ClinicalTrials.gov ID: NCT02153476
Acronym / sponsor ID: VMA-202
Conditions: Symptomatic Focal Vitreomacular Adhesion
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Allegro Ophthalmics, LLCIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 3 Jun 2014 (estimated)
Results: Posted 18 Jul 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG-1001 in human subjects with symptomatic focal vitreomacular adhesion

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
2.0mg of ALG-1001	Experimental	Drug: 2.0mg of ALG-10012.0mg of ALG-1001
Intravitreal injection in 0.05cc balanced salt solution.	Placebo comparator	Drug: Balanced Salt SolutionBalanced Salt Solution

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Symptomatic focal vitreomacular adhesion
Vitreomacular traction syndrome
Stage 1 and 2 macular holes, ≤ 350 µm
BCVA of 20/25 Early Treatment Diabetic Retinopathy Study (ETDRS) or worse in the study eye
BCVA of 20/800 ETDRS or better in the fellow eye

Key exclusion criteria (12 listed)

High myopes > -8.0 D spherical equivalent
History of prior vitrectomy in the study eye
History of photocoagulation to the retina in the study eye
Macular hole in the study eye > 350 µm
Subjects with epiretinal membranes in the study eye

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
2.0mg of ALG-1001	Drug	2.0mg of ALG-1001
Balanced Salt Solution	Drug	Intravitreal injection in 0.05cc balanced salt solution.

Primary outcome

Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)
Time frame: 90 Days
The primary endpoint of this study is observation of pharmacologic resolution of VMA, with VMA defined as vitreous adhesion to the macula within a 6mm central retinal field surrounded by elevation of the posterior vitreous cortex as seen on OCT.

Results and safety

Results posted to the registry on 18 Jul 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2.0mg of ALG-1001	23	22
Intravitreal Injection in 0.05cc BSS	22	22

Primary outcome: Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT)

Time frame: 90 Days. Count of participants. Unit: Participants

Measure	2.0mg of ALG-1001 n = 23	Intravitreal Injection in 0.05cc BSS n = 22
Value	4	0

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2.0mg of ALG-1001	0 of 23 (0%)	0 of 23 (0%)	0 of 23
Intravitreal Injection in 0.05cc BSS	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

The record lists no contact. Use the official record to reach the sponsor.

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 2.0mg of ALG-1001 and Balanced Salt Solution in people with Symptomatic Focal Vitreomacular Adhesion, run by Allegro Ophthalmics, LLC at 5 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 7 inclusion and 12 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 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Release of Vitreo Macular Adhesion (VMA) by Optical Coherence Tomography (OCT) (time frame: 90 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153476.

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 19 Dec 2018.