Non Infectious UveitisPhase 3NCT03711929
LUMINA Phase III Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 Sirolimus for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye
A Phase 3 study testing DE-109 Intravitreal Injections and DE-109 Intravitreal Injections (Open Label) in people with Non Infectious Uveitis, run by Santen Inc. at 65 sites in 4 countries.
Trial summary
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Infectious Uveitis
- What is being tested?
- DE-109 Intravitreal Injections and DE-109 Intravitreal Injections (Open Label)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 145 participants
- Where
- 65 sitesin 4 countries
- Study dates
- 19 Nov 2018to 14 Jun 2022
- Phase
- Phase 3
- 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
- Non-Infectious Active Uveitis of the Posterior Segment
Who cannot join
- Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
Trial locations and contacts
65 sites in 4 countries.
65 sites in 4 countries
United States38 sites
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109
Emory Eye Center
Atlanta, Georgia, 30322
Austin Retina Associate
Austin, Texas, 78705
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02673
Cook County Health & Hospitals System
Chicago, Illinois, 60612
Cleveland Clinic Cole Eye Institute
Cleveland, Ohio, 44195
Texas Retina Associates-Dallas-Main
Dallas, Texas, 75231
Kresge Eye Institute
Detroit, Michigan, 48201
Cascade Medical Research Institute, LLC
Eugene, Oregon, 97401
Retina Group of Washington
Fairfax, Virginia, 22031
Colorado Retina Associates
Golden, Colorado, 80401
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Houston Eye Associates
Houston, Texas, 77025
Retina Consultants of Houston
Houston, Texas, 77030
Discover Vision Center
Independence, Missouri, 64055
Raj K.Maturi, MD
Indianapolis, Indiana, 46290
Kaiser Permanente Medical Center
Los Angeles, California, 90027
USC Roski Eye Institute
Los Angeles, California, 90032
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute
McAllen, Texas, 78503
Retina Vitreous Consultants
Monroeville, Pennsylvania, 15146
West Virginia University Eye Institute
Morgantown, West Virginia, 26506
Vanderbilt Eye Institute
Nashville, Tennessee, 37215
New York Eye & Ear Infirmary of Mt. Sinai
New York, New York, 10003
Illinois Retina Associate
Oak Park, Illinois, 60304
Byers Eye Institute at Stanford
Palo Alto, California, 94303
California Eye Specialist Medical Group, Inc.
Pasadena, California, 91107
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Arizona Retina & Vitreous Consultants
Phoenix, Arizona, 85021
UPMC Eye Center
Pittsburgh, Pennsylvania, 15213
University of Kansas School of Medicine
Prairie Village, Kansas, 66208
Associated Retina Consultants-Royal Oak
Royal Oak, Michigan, 48073
Foresight Studies, San Antonio
San Antonio, Texas, 78217
Medical Center Ophthalmology Associate
San Antonio, Texas, 78240
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33711
University of South Florida Eye Institute
Tampa, Florida, 33612
Wake Forest Baptist Medical Center/Surgery
Winston-Salem, North Carolina, 27157
India14 sites
Banker's Retina Clinic & Laser Centre
Ahmedabad, Gujarat, 380009
Narayana Nethralaya
Bangalore, Karnataka, 560010
LV Prasad Eye Institute
Bhubaneswar, Odisha, 751024
Advanced Eye Center
Chandigarh, 160012
Sankara Nethralaya
Chennai, Tamil Nadu, 600006
Aravind Eye Hospital (Coimbatore)
Coimbatore, Tamil Nadu, 641014
Sri Sankaradeva Nethralaya
Guwahati, Assam, 781028
L V Prasad Eye Institute
Hyderabad, Telangana, 500034
SMS Hospital
Jaipur, Rajasthan, 302004
Dr. J.L. Rohatgi Memorial Eye Hospital
Kanpur, Uttar Pradesh, 208005
BB Eye Foundation
Kolkata, West Bengal, 700059
Aravind Eye Hospitals
Madurai, Tamil Nadu, 625020
Disha Eye Hospitals Pvt Ltd
Pune, Maharashtra, 411060
PBMA'S H. V. Desai Eye Hospital
Pune, Maharashtra, 411060
Argentina8 sites
Primer Hospital Privado De Ojos
Buenos Aires, Buenos Aires F.D., C1033AAW
Hospital Universitario Austral
Buenos Aires, Buenos Aires F.D., C1425BGR
Gustavo Ariel Budmann Private Office
Buenos Aires, Odisha, 1426
Organización Médica de Investigación (OMI)
Caba, C1015ABO
Centro Privado de Ojos Romagosa Fundacion VER
Córdoba, 5000
Centro De Ojos Loria SRL
Lomas de Zamora, Buenos Aires, B1832IXE
Clinica Privada de Ojos
Mar del Plata, Buenos Aires, B7600DFC
Oftalmologia Global
Rosario, Santa Fe Province, 2000
Italy5 sites
A.O.U. Policlinico SantOrsola-Malpigi
Bologna, 40138
Polo Universita degli Studi di Milano Ospedale Luigi Sacco Clinca Oculistica (Eye Clinic)
Milan, Lombardy, 20157
San Raffaele Scientific Institute
Milan, 20122
Universita degli Studi di Padova - Azienda Ospedaliera di Padova - Clinica Oculistica
Padova, Veneto, 35128
Azienda USL IRCCS Reggio Emilia
Reggio Emilia, 42123
About this study
Official title: LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).
There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.
- Conditions
- Non Infectious Uveitis
- Being tested
- DE-109 Intravitreal Injections, Sham Procedure, DE-109 Intravitreal Injections (Open Label)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DE-109 Intravitreal InjectionsDrug
440 ug of DE-109 Injectable Solution
Sham ProcedureOther
The sham procedure mimics an intravitreal injection without penetrating the eye.
DE-109 Intravitreal InjectionsDrug
Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
DE-109 Intravitreal Injections (Open Label)Drug
After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10)
| Study group | Role | What they receive |
|---|---|---|
| Test Arm: DE-109 Injectable Solution | Experimental | Intravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). Receives: Drug: DE-109 Intravitreal Injections |
| Control Arm: Sham Procedure | Sham comparator | Sham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye. Receives: Other: Sham Procedure |
| Dummy Arm: DE-109 Injectable Solution | Other | Dummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). Receives: Drug: DE-109 Intravitreal Injections |
| Open-label:DE-109 Injectable Solution | Experimental | Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing. Receives: Drug: DE-109 Intravitreal Injections (Open Label) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitreous Haze (VH) of Zero Response at Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
- Score = 0: No inflammation
- Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
- Score = 1+: Mild blurring of the retinal vessels and optic nerve
- Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
- Score = 2+: Moderate blurring of the optic nerve head
- Score = 3+: Marked blurring of the optic nerve head
- Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
Measured: Month 5
Secondary outcomes (2)
Mean Composite Score at Month 3 and Month 5
Composite score scale is defined as follows. Each study eye was assigned one of the following scores:
- Score = 3 if a study eye achieved Vitreous Haze (VH) score of 0 at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
- Score = 2 if a study eye had at least improved (decreased) by 2 units (i.e., 2+ to 0, 3+ to 1+, or 4+ to 2+) in VH (compared to baseline) at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
- Score = 1 if a study eye achieved VH score of 0.5+ at the specified visit without taking any rescue therapies that could affect VH score prior to the specified visit.
- Score = -1 if a study eye got rescued due to worsening of uveitis or discontinued from the study due to lack of efficacy or due to adverse event prior to the specified visit.
- Score = 0 if otherwise
Measured: Month 3, Month 5
Vitreous Haze (VH) of Zero Response at Month 3
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows:
- Score = 0: No inflammation
- Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex)
- Score = 1+: Mild blurring of the retinal vessels and optic nerve
- Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+
- Score = 2+: Moderate blurring of the optic nerve head
- Score = 3+: Marked blurring of the optic nerve head
- Score = 4+: Optic nerve head not visible
VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale.
The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 3.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start19 Nov 2018
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Why it stopped: Business decision
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non Infectious UveitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711929
- Sponsor's protocol ID
- 010906IN
- Status last verified
- Nov 2023
- First submitted
- 17 Oct 2018
- Last updated
- 4 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Hashida N, Nishida K. Recent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases. Adv Drug Deliv Rev. 2023 Jul;198:114870. doi: 10.1016/j.addr.2023.114870. Epub 2023 May 10.
PubMed 37172783
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LUMINA: A Phase III, Multicenter, Sham-Controlled, Randomized, Double-Masked Study Assessing the Efficacy and Safety of Intravitreal Injections of 440 ug DE-109 for the Treatment of Active, Non-Infectious Uveitis of the Posterior Segment of the Eye.
- ClinicalTrials.gov ID
- NCT03711929
- Acronym / sponsor ID
- 010906IN
- Conditions
- Non Infectious Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business decision
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Santen Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase III study to assess the efficacy and safety of DE-109 440 µg every 2 months in subjects with active, non-infectious uveitis of the posterior segment of the eye (NIU-PS).
There is a 6-month, single-arm, open-label period after completion of the 6-month double- masked, controlled period allows the evaluation of the efficacy and safety of intravitreal injection of DE-109 440 µg every 2 months for longer duration than appropriate for a placebo or sham control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test Arm: DE-109 Injectable Solution | Experimental | Drug: DE-109 Intravitreal InjectionsIntravitreal injection of DE-109 440 µg in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). |
| Control Arm: Sham Procedure | Sham comparator | Other: Sham ProcedureSham procedure administered to the study eye(s) every 2 months (Day 1, Month 2, and Month 4). The sham procedure mimics an intravitreal injection without penetrating the eye. |
| Dummy Arm: DE-109 Injectable Solution | Other | Drug: DE-109 Intravitreal InjectionsDummy Arm: Intravitreal injection of DE-109 at an undisclosed, fixed dose (within the range of 44 µg to 880 µg) in the study eye(s) every 2 months (Day 1, Month 2, and Month 4). |
| Open-label:DE-109 Injectable Solution | Experimental | Drug: DE-109 Intravitreal Injections (Open Label)Subjects completing the Month 6 pre-dose evaluations (the final evaluations in the double-masked period) began the open-label period of the study, in which all subjects received intravitreal injection of DE-109 440 μg in the study eye(s) every 2 months for an additional 6 months of dosing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Non-Infectious Active Uveitis of the Posterior Segment
Key exclusion criteria (1 listed)
- Females who are pregnant, nursing, or planning a pregnancy Confirmed or suspected infectious uveitis
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 |
|---|---|---|
| DE-109 Intravitreal Injections440 ug of DE-109 Injectable Solution | Drug | Test Arm: DE-109 Injectable Solution |
| Sham ProcedureThe sham procedure mimics an intravitreal injection without penetrating the eye. | Other | Control Arm: Sham Procedure |
| DE-109 Intravitreal InjectionsUndisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug) | Drug | Dummy Arm: DE-109 Injectable Solution |
| DE-109 Intravitreal Injections (Open Label)After double-masked treatment period (injections every 2 months), eligible subjects would enter the open-labeled period and had DE-109 440 ug injections every 2 months (Month 6, Month 8, and Month 10) | Drug | Open-label:DE-109 Injectable Solution |
Primary outcome
Vitreous Haze (VH) of Zero Response at Month 5
Time frame: Month 5
Vitreous Haze (VH) was assessed during slit-lamp biomicroscopy and scored using the modified Standardized Uveitis Nomenclature (SUN) scale as follows: * Score = 0: No inflammation * Score = 0.5+: Trace inflammation (slight blurring if the optic disc margins and/or loss of nerve fiber layer reflex) * Score = 1+: Mild blurring of the retinal vessels and optic nerve * Score = 1.5+: Optic nerve had and posterior retina view obstruction greater than 1+ but less than 2+ * Score = 2+: Moderate blurring of the optic nerve head * Score = 3+: Marked blurring of the optic nerve head * Score = 4+: Optic nerve head not visible VH 0 response (resolution of inflammation) is defined as a VH score of 0 in the study eye at a specified follow up visit based on the modified SUN scale. The response as a percentage is calculated as the proportion of study eyes which achieved a VH score of zero at Month 5
2 secondary outcomes
Mean Composite Score at Month 3 and Month 5
Time frame: Month 3, Month 5
Vitreous Haze (VH) of Zero Response at Month 3
Time frame: Month 3
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37172783Hashida N, Nishida K. Recent advances and future prospects: Current status and challenges of the intraocular injection of drugs for vitreoretinal diseases. Adv Drug Deliv Rev. 2023 Jul;198:114870. doi: 10.1016/j.addr.2023.114870. Epub 2023 May 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
65 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DE-109 Intravitreal Injections and DE-109 Intravitreal Injections (Open Label) in people with Non Infectious Uveitis, run by Santen Inc. at 65 sites in 4 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 1 inclusion and 1 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 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, India, Argentina, Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 4 Dec 2023). 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?
Vitreous Haze (VH) of Zero Response at Month 5 (time frame: Month 5). 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 NCT03711929, which also lists 1 linked publication.
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 4 Dec 2023.