Diabetic RetinopathyPhase 2CIRCLENCT02681809

A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

A Phase 2 study testing ocriplasmin 0.0625mg and ocriplasmin 0.125mg in people with Diabetic Retinopathy and Posterior Vitreous Detachment, run by ThromboGenics at 38 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderate to very severe non-proliferative diabetic retinopathy (NPDR), to induce total posterior vitreous detachment (PVD) in order to reduce the risk of disease… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression
What is being tested?: ocriplasmin 0.0625mg and ocriplasmin 0.125mg
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 48 participants
Where: 38 sitesin 9 countries
Study dates: Dec 2015to 18 Nov 2019
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

Male or female aged 18 years or older
Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
HbA1c ≤ 12%, as assessed by the central laboratory
Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema
No evidence of total PVD in the study eye
Written informed consent obtained from the subject prior to screening procedures

Who cannot join

History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
Presence of epiretinal membrane in the study eye
Presence of foveal ischemia in the study eye
Presence of pre-retinal or vitreous haemorrhage in the study eye
Presence of iris or angle neovascularisation in the study eye
Any active ocular / intraocular infection or inflammation in either eye

Show all 9Show fewer

Aphakic study eye
Uncontrolled hypertension in the opinion of the Investigator
Pseudoexfoliation, Marfan's syndrome, phacodonesis or any other finding in the Investigator's opinion suggesting lens / zonular instability

Trial locations and contacts

38 sites in 9 countries.

Country

City, postcode or hospital

38 sites in 9 countries

United States9 sites

Study site
Campbell, California, 95008
Study site
Charlottesville, Virginia, 22903
Study site
Irvine, California, 92697
Study site
Loma Linda, California, 92354
Study site
McAllen, Texas, 78503
Study site
Phoenix, Arizona, 85021
Study site
Rapid City, South Dakota, 57701
Study site
San Antonio, Texas, 78240
Study site
Santa Ana, California, 92705

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Czechia7 sites

Study site
Brno, 625 00
Study site
Hradec Králové, 500 05
Study site
Olomouc, 779 00
Study site
Pardubice, 530 02
Study site
Prague, 100 34
Study site
Prague, 140 00
Study site
Zlín, 760 01

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Hungary6 sites

Study site
Budapest, 1062
Study site
Budapest, 1083
Study site
Budapest, 1106
Study site
Budapest, 1133
Study site
Debrecen, Hajdú-Bihar, 4032
Study site
Szombathely, 9700

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Israel4 sites

Study site
Beersheba, 84101
Study site
Petah Tikva, 4941492
Study site
Rehovot, 7610001
Study site
Tel Aviv, 6423906

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Spain4 sites

Study site
Barcelona, 08195
Study site
Barcelona, 8025
Study site
Girona, 17007
Study site
Valladolid, 47012

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Germany3 sites

Study site
Darmstadt, Hesse, 64297
Study site
Leipzig, Saxony, 04103
Study site
München, Bavaria, 80336

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United Kingdom3 sites

Study site
Frimley, Surrey, GU16 7UJ
Study site
London, EC1V 2PD
Study site
London, SE5 9RS

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France1 site

Study site
Paris, 75475

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Italy1 site

Study site
Milan, 20132

Other trials in Italy

About this study

Official title: A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)

Conditions: Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression
Being tested: ocriplasmin 0.0625mg, ocriplasmin 0.125mg, Sham injection
Medical subject headings: Diabetic Retinopathy, Vitreous Detachment, Disease Progression

What participants receive

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

ocriplasmin 0.0625mgDrug
Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
ocriplasmin 0.125mgDrug
Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
Sham injectionDrug
3 sham injections approximately 1 month apart. No actual injections. No medication is used.

Study groups in NCT02681809
Study group	Role	What they receive
Ocriplasmin 0.0625mg	Experimental	Not described Receives: Drug: ocriplasmin 0.0625mg
Ocriplasmin 0.125mg	Experimental	Not described Receives: Drug: ocriplasmin 0.125mg
Sham injection	Sham comparator	Not described Receives: Drug: Sham injection

What is being measured

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

Number of Subjects With Total PVD by the Month 3 Visit
Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres
Measured: Month 3

Secondary outcomes (1)

Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
Adverse events were identified by ophthalmic assessments (including BCVA assessment, full ophthalmic examination and ocular imaging) and by subject reporting
Measured: From first injection until the end of the study (Month 24)

Timeline

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

Dec 201518 Nov 2019

First posted12 Feb 2016 (estimated)
Study startDec 2015
Primary completion18 Nov 2019
Study completion18 Nov 2019

Why it stopped: Slow recruitment rate

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 Diabetic RetinopathyStudies 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: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02681809
Sponsor's protocol ID: TG-MV-015
Other IDs: 2015-002415-15, 2015
Acronym: CIRCLE
Status last verified: Dec 2020
First submitted: 5 Feb 2016
Last updated: 16 Dec 2020
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
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All Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Randomised, Double Masked, Sham Controlled, Multicentre Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total Posterior Vitreous Detachment (PVD) in Subjects With Non-proliferative Diabetic Retinopathy (NPDR)
ClinicalTrials.gov ID: NCT02681809
Acronym / sponsor ID: CIRCLE / TG-MV-015
Conditions: Diabetic Retinopathy, Posterior Vitreous Detachment, Disease Progression
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow recruitment rate
Enrolment: 48 participants (actual)
Lead sponsor: ThromboGenicsIndustry (pharma, biotech, devices)
Study start: Dec 2015
Primary completion: 18 Nov 2019 (actual)
Study completion: 18 Nov 2019 (actual)
First posted: 12 Feb 2016 (estimated)
Results: Posted 16 Dec 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Ocriplasmin 0.0625mg	Experimental	Drug: ocriplasmin 0.0625mg
Ocriplasmin 0.125mg	Experimental	Drug: ocriplasmin 0.125mg
Sham injection	Sham comparator	Drug: Sham injection

Who may qualify

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

Key inclusion criteria (7 listed)

Male or female aged 18 years or older
Best-corrected visual acuity (BCVA) of 65 letters read or greater (Snellen equivalent of 20/50 or better) in the study eye
HbA1c ≤ 12%, as assessed by the central laboratory
Moderate to very severe NPDR as per ETDRS Severity Scale, based on 7 standard field stereo colour fundus photograph
Central subfield thickness of ≤ 340µm on Spectralis SD-OCT or ≤ 320µm on non-Spectralis SD OCT in the study eye, with or without mild centre-involved diabetic macular oedema

Key exclusion criteria (9 listed)

History of or current ocular condition in the study eye that may interfere with the assessment of the progression to PDR
Presence of epiretinal membrane in the study eye
Presence of foveal ischemia in the study eye
Presence of pre-retinal or vitreous haemorrhage in the study eye
Presence of iris or angle neovascularisation 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
ocriplasmin 0.0625mgUp to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart	Drug	Ocriplasmin 0.0625mg
ocriplasmin 0.125mgUp to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart	Drug	Ocriplasmin 0.125mg
Sham injection3 sham injections approximately 1 month apart. No actual injections. No medication is used.	Drug	Sham injection

Primary outcome

Number of Subjects With Total PVD by the Month 3 Visit
Time frame: Month 3
Total PVD should be confirmed on both B-scan ultrasound and spectral domain optical coherence tomography (SD-OCT), as assessed by the masked central reading centres

1 secondary outcome

Number of Subjects With Ocular Treatment-emergent Adverse Events in the Study Eye
Time frame: From first injection until the end of the study (Month 24)

Results and safety

Results posted to the registry on 16 Dec 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ocriplasmin 0.0625mg	20	15
Ocriplasmin 0.125mg	19	15
Sham Injection	9	8

Primary outcome: Number of Subjects With Total PVD by the Month 3 Visit

Time frame: Month 3. Count of participants. Unit: Participants

Measure	Ocriplasmin 0.0625mg n = 20	Ocriplasmin 0.125mg n = 18	Sham Injection n = 8
Value	0	0	0

Population analysed: All Treated Subjects with B-scan ultrasound and SD-OCT assessments at Month 3

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From first injection until the end of the study (Month 24). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocriplasmin 0.0625mg	5 of 20 (25%)	16 of 20 (80%)	0 of 20
Ocriplasmin 0.125mg	8 of 19 (42.1%)	17 of 19 (89.5%)	0 of 19
Sham Injection	1 of 9 (11.1%)	7 of 9 (77.8%)	0 of 9

Limitations and caveats (from the sponsor): Recruitment in the study was discontinued early due to slow recruitment rate. This led to 48 randomized subjects instead of the planned 115. By consequence, the study was not powered for its primary endpoint, which was evaluated only descriptively.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Recruiting
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Active, not recruitingObservational study
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Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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Recruiting
To Investigate the Feasibility and Acceptability of Trained Non-medical Professionals Performing Laser Treatment for Proliferative Diabetic Retinopathy (PDR), and the Potential Impact on Service Capacity. Assess Feasibility of Conducting a Full Trial Comparing Trained ECPs With Ophthalmologists
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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.

Clinical Department study director

ThromboGenics

38 sites in 9 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ocriplasmin 0.0625mg and ocriplasmin 0.125mg in people with Diabetic Retinopathy and Posterior Vitreous Detachment, run by ThromboGenics at 38 sites in 9 countries.

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 9 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: stopped early, as of the sponsor's last update on 16 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 38 sites in United States, Czechia, Hungary, Israel, Spain and 4 more countries. 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 16 Dec 2020). 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?

Number of Subjects With Total PVD by the Month 3 Visit (time frame: Month 3). 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 NCT02681809.

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 16 Dec 2020.