Diabetic Macular EdemaPhase 2NCT02348918

Phase 2 Randomized Clinical Trial of Luminate® as Compared to Avastin® in the Treatment of Diabetic Macular Edema

A Phase 2 study testing Luminate 1.0mg, Luminate 2.0mg and Luminate 3.0mg in people with Diabetic Macular Edema, run by Allegro Ophthalmics, LLC at 17 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

A Phase 2 Multi center, Randomized, Controlled, Double-Masked Clinical Trial Designed To Evaluate The Safety And Exploratory Efficacy Of Luminate® (Alg-1001) As Compared To Avastin® In The Treatment Of Diabetic Macular Edema Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Diabetic Macular Edema
What is being tested?: Luminate 1.0mg, Luminate 2.0mg and Luminate 3.0mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 218 participants
Where: 17 sitesUnited States
Study dates: 13 Oct 2014to 13 Jun 2017
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, 18 years of age or older.
Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.
Intra-Ocular Pressure (IOP) is under control (i.e., IOP

Show all 10Show fewer

≤ 25 mm in the study eye) and study eye is not receiving any IOP lowering drops.
Willing and able to return for all study visits.
Able to meet the extensive post-op evaluation regimen.
Understands and signs the informed consent form.

Who cannot join

Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
Screening HgA1c blood test > 10.0
Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.
History of rhegmatogenous retinal detachment, retinal tear(s), or traction retinal detachments in the study eye.

Show all 22Show fewer

Epiretinal membrane and/or vitreomacular traction in the study eye as determined by the central reading center.
Previous pars plana vitrectomy in the study eye
Any intraocular surgery in the study eye within the last 90 days prior to study enrollment.
YAG laser treatment in the study eye in last 30 days prior to study enrollment.
High myopia in the study eye, with a spherical equivalent of >8.00D at screening
Other ocular pathologies that in the investigator's opinion would interfere with the subject's vision in the study eye.
Chronic or recurrent uveitis.
Ongoing ocular infection or inflammation in either eye.
A history of cataract surgery complications/vitreous loss in the study eye.
Congenital eye malformations in the study eye.
A history of penetrating ocular trauma in the study eye.
Mentally handicapped.
Pregnant female, as determined for women less than 60 years old by a positive urine pregnancy test during the screening window.
Nursing female.
Currently participating in any other clinical research study.
Contraindication to the study medication.

Trial locations and contacts

17 sites in 1 country.

City, postcode or hospital

17 sites in 1 country

United States17 sites

Florida Eye Clinic
Altamonte Springs, Florida, 32701
Austin Retina Associates
Austin, Texas, 78705
Wilmer Eye Institute at John Hopkins University
Baltimore, Maryland, 21205
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
Charlotte EENT Associates
Charlotte, North Carolina, 28210
Retina Consultant of Houston
Houston, Texas, 77098
TLC Eye Group
Jackson, Michigan, 49202
Northern California Retina Vitreous Associates
Mountain View, California, 94040
New England Retina Associates
New London, Connecticut, 06320
Retina Specialty Institute
Pensacola, Florida, 32503
Associated Retina Consultants
Phoenix, Arizona, 85020
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
West Coast Retina
San Francisco, California, 94109
Orange County Retina Medical Group
Santa Ana, California, 92705
Island Retina
Shirley, New York, 11967
Spokane Eye Clinical Research
Spokane, Washington, 99204
Center for Retina and Macular Disease
Winter Haven, Florida, 33880

Other trials in United States

About this study

Official title: A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)

Read the detailed description

To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema

Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).

Stage 2 (select sites): 75 eligible subjects with DME will be enrolled and randomized to one of 5 treatment groups at an allocation ratio of 1:1:1:1:1; i.e., one of 2 doses of Luminate intravitreal injection or Avastin intravitreal injection (0.5 mg and 1.0 mg). Subjects will be followed monthly for 20 weeks (5 months).

Conditions: Diabetic Macular Edema
Being tested: Luminate 1.0mg, Luminate 2.0mg, Luminate 3.0mg, Avastin, Luminate 0.5mg

What participants receive

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

Luminate 1.0mgDrug
Also called ALG-1001
Luminate 2.0mgDrug
Also called ALG-1001
Luminate 3.0mgDrug
Also called ALG-1001
AvastinDrug
Also called bevacizumab
Luminate 0.5mgDrug
Also called ALG-1001

Study groups in NCT02348918
Study group	Role	What they receive
Luminate 1.0mg group	Active comparator	Stage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Receives: Drug: Luminate 1.0mg
Luminate 2.0mg group	Active comparator	Stage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Receives: Drug: Luminate 2.0mg
Luminate 3.0mg group	Active comparator	Stage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks. Receives: Drug: Luminate 3.0mg
Avastin® group	Active comparator	Stage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required. Receives: Drug: Avastin
Avastin then Luminate 1.0 mg IVT + sham injection	Active comparator	Stage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT Receives: Drug: Luminate 1.0mg; Drug: Avastin
Avastin then Luminate 0.5 mg IVT + sham injection	Active comparator	Stage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT Receives: Drug: Avastin; Drug: Luminate 0.5mg
Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT	Active comparator	Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Receives: Drug: Luminate 1.0mg; Drug: Avastin
Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT	Active comparator	Stage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT Receives: Drug: Avastin; Drug: Luminate 0.5mg
Avastin 1.25 mg + Sham IVT	Active comparator	Stage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN Receives: Drug: Luminate 0.5mg

What is being measured

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

Change in BCVA at Week 24
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline
Measured: Value of 24 Weeks minus baseline value

Timeline

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

13 Oct 201413 Jun 2017

First posted28 Jan 2015 (estimated)
Study start13 Oct 2014
Primary completion16 May 2017
Study completion13 Jun 2017

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 Macular EdemaStudies 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: 218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02348918
Sponsor's protocol ID: DME 202B
Status last verified: Dec 2018
First submitted: 12 Jan 2015
Last updated: 7 Dec 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

All Diabetic Macular Edema trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2 Randomized, Controlled, Double-Masked, Multicenter Clinical Trial Designed to Evaluate the Safety and Exploratory Efficacy of Luminate® (ALG-1001) as Compared to Avastin® in the Treatment of Diabetic Macular Edema (DME)
ClinicalTrials.gov ID: NCT02348918
Acronym / sponsor ID: DME 202B
Conditions: Diabetic Macular Edema
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 218 participants (actual)
Lead sponsor: Allegro Ophthalmics, LLCIndustry (pharma, biotech, devices)
Collaborators: Trial Runners, LLC, Duke University
Study start: 13 Oct 2014 (actual)
Primary completion: 16 May 2017 (actual)
Study completion: 13 Jun 2017 (actual)
First posted: 28 Jan 2015 (estimated)
Results: Posted 7 Dec 2018

Clinical summary

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

Detailed description

To evaluate the safety and efficacy of Luminate® (ALG-1001) as compared to Avastin® in patients with diabetic macular edema

Stage 1: 120 eligible subjects with DME will be enrolled and randomized to one of 4 treatment groups at an allocation ratio of 1:1:1:1, i.e., one of three doses (1.0 mg, 2.0 mg and 3.0 mg) of Luminate intravitreal injection or Avastin intravitreal injection. Subjects will be followed monthly for 24 weeks (6 months).

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 9

Arm	Type	Receives
Luminate 1.0mg group	Active comparator	Drug: Luminate 1.0mgStage 1- Luminate 1.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 2.0mg group	Active comparator	Drug: Luminate 2.0mgStage 1 -Luminate 2.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week 20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Luminate 3.0mg group	Active comparator	Drug: Luminate 3.0mgStage 1- Luminate 3.0 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Luminate injection at week20 for a total of at least 3 and no more than 4 Luminate injections. Sham injections will be performed at weeks 12 and 16 and may also be performed at week 20 if prn Luminate is not required; sham laser treatment will be administered at baseline and at 16 weeks.
Avastin® group	Active comparator	Drug: AvastinStage 1- Avastin 1.25 mg intravitreal injection administered at baseline (Day 0), 4 weeks and 8 weeks with prn Avastin injection at weeks 12, 16, or 20 for a total of at least 3 and up to 6 Avastin injections. Sham injections may be performed at weeks 12, 16, and 20 if prn Avastin is not required.
Avastin then Luminate 1.0 mg IVT + sham injection	Active comparator	Drug: Luminate 1.0mg, Drug: AvastinStage 2 - Week 0 (Baseline): Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 1.0 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Avastin then Luminate 0.5 mg IVT + sham injection	Active comparator	Drug: Avastin, Drug: Luminate 0.5mgStage 2- Week 0 (Baseline); Avastin 1.25 mg IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + sham injection Weeks 12 and 16: Sham IVT
Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT	Active comparator	Drug: Luminate 1.0mg, Drug: AvastinStage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Luminate 1.0 mg + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT	Active comparator	Drug: Avastin, Drug: Luminate 0.5mgStage 2 : Week 0: Sham IVT Weeks 1, 4 and 8: Luminate 0.5 mg IVT + Avastin 1.25 mg IVT Weeks 12 and 16: Sham IVT
Avastin 1.25 mg + Sham IVT	Active comparator	Drug: Luminate 0.5mgStage 2 : Week 0 (Baseline): Sham IVT Weeks 1, 4 and 8: Avastin 1.25 mg + Sham IVT Weeks 12 and 16: Avastin PRN

Who may qualify

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

Key inclusion criteria (10 listed)

Male or female, 18 years of age or older.
Study eye with clinically significant diabetic macular edema (DME) with central subfield thickness ≥ 350µm on spectral domain OCT
Best corrected visual acuity (BCVA) of 20/50 to 20/320 ETDRS equivalent (65 letters to 23 letters) in the study eye, with BCVA decrement primarily attributable to DME.
Treatment naïve, i.e., no previous anti-VEGF treatment in the study eye or no anti-VEGF treatment in the 45 days prior to study enrollment.
In the investigator's opinion, the subject still has significant intraretinal fluid with room for improvement in both macular edema and BCVA.

Key exclusion criteria (22 listed)

Active proliferative diabetic retinopathy (PDR) in the study eye such as NVE, NVD, vitreous hemorrhage, or neovascular glaucoma.
Uncontrolled hypertension defined as systolic >180 mmHg or > 160 mmHg on 2 consecutive measurements or diastolic > 100 mmHg on optimal medical regimen
Screening HgA1c blood test > 10.0
Focal laser photocoagulation or intravitreal/periocular steroids of any type in the study eye within the last 90 days prior to study enrollment.
A history of intravitreal anti-VEGF injection of any type in the study eye within the last 45 days prior to study enrollment.

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
Luminate 1.0mgAlso: ALG-1001	Drug	Avastin then Luminate 1.0 mg IVT + sham injection, Luminate 1.0mg group, Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT
Luminate 2.0mgAlso: ALG-1001	Drug	Luminate 2.0mg group
Luminate 3.0mgAlso: ALG-1001	Drug	Luminate 3.0mg group
AvastinAlso: bevacizumab	Drug	Avastin then Luminate 0.5 mg IVT + sham injection, Avastin then Luminate 1.0 mg IVT + sham injection, Avastin® group, Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT, Sham then Luminate 1.0 mg + Avastin 1.25 mg IVT
Luminate 0.5mgAlso: ALG-1001	Drug	Avastin 1.25 mg + Sham IVT, Avastin then Luminate 0.5 mg IVT + sham injection, Sham then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT

Primary outcome

Change in BCVA at Week 24
Time frame: Value of 24 Weeks minus baseline value
Primary efficacy outcome is BCVA changes at Week 24 as compared to baseline

Results and safety

Results posted to the registry on 7 Dec 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
Luminate 1.0mg Group	39	39
Luminate 2.0mg Group	33	33
Luminate 3.0mg Group	42	42
Avastin® Group	24	24
Avastin Then Luminate 1.0 mg IVT + Sham Injection	19	19
Avastin Then Luminate 0.5 mg IVT + Sham Injection	17	17
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT	13	13
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT	16	16
Avastin 1.25 mg + Sham IVT	15	15

Primary outcome: Change in BCVA at Week 24

Time frame: Value of 24 Weeks minus baseline value. Mean (Standard Error). Unit: Letters on ETDRS eye chart

Measure	Luminate 1.0mg Group n = 39	Luminate 2.0mg Group n = 33	Luminate 3.0mg Group n = 42	Avastin® Group n = 24	Avastin Then Luminate 1.0 mg IVT + Sham Injection n = 19	Avastin Then Luminate 0.5 mg IVT + Sham Injection n = 17	Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT n = 13	Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT n = 16	Avastin 1.25 mg + Sham IVT n = 15
Value	5.2 (3)	2.7 (3)	-1.5 (3)	7 (3)	7.1 (3)	4.6 (3)	1.4 (3)	3.9 (3)	6.7 (3)

Adverse events

Time frame: The adverse events were collected from October 13, 2014 thru May 16th 2017 (2 years 7 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Luminate 1.0mg Group	8 of 39 (20.5%)	28 of 39 (71.8%)	1 of 39
Luminate 2.0mg Group	3 of 33 (9.1%)	20 of 33 (60.6%)	0 of 33
Luminate 3.0mg Group	6 of 42 (14.3%)	25 of 42 (59.5%)	1 of 42
Avastin® Group	3 of 24 (12.5%)	16 of 24 (66.7%)	1 of 24
Avastin Then Luminate 1.0 mg IVT + Sham Injection	2 of 19 (10.5%)	10 of 19 (52.6%)	0 of 19
Avastin Then Luminate 0.5 mg IVT + Sham Injection	1 of 17 (5.9%)	5 of 17 (29.4%)	0 of 17
Sham Then Luminate 1.0 mg + Avastin 1.25 mg IVT	1 of 13 (7.7%)	6 of 13 (46.2%)	0 of 13
Sham Then Luminate 0.5 mg IVT + Avastin 1.25 mg IVT	2 of 16 (12.5%)	7 of 16 (43.8%)	0 of 16
Avastin 1.25 mg + Sham IVT	3 of 15 (20%)	3 of 15 (20%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Diabetic Macular Edema

Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingPhase 2
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
Diabetic Retinopathy, DR
RecruitingPhase 3
A Phase 3 Trial for Intravitreal Injection of 4D-150 in Adults With Diabetic Macular Edema (DME).
Diabetic Macular Edema (DME)
RecruitingPhase 2
Oral N-Acetylcysteine on Diabetic Macular Edema
Diabetic Macular Edema (DME)
Active, not recruitingPhase 3
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Diabetic Macular Edema, DME

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.

Vicken Karageozian study director

Cheif Medical Officer

17 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 Luminate 1.0mg, Luminate 2.0mg and Luminate 3.0mg in people with Diabetic Macular Edema, run by Allegro Ophthalmics, LLC at 17 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 10 inclusion and 22 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 7 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 17 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 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 7 Dec 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?

Change in BCVA at Week 24 (time frame: Value of 24 Weeks minus baseline value). 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 NCT02348918.

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 7 Dec 2018.