Diabetic Macular OedemaPhase 2ARA290DMONCT06626971
The Use of ARA290 for the Treatment of Diabetic Macular Oedema
A Phase 2 study testing ARA290 in people with Diabetic Macular Oedema, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial summary
ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Oedema
- What is being tested?
- ARA290
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Aug 2017
- Phase
- Phase 2
- 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
- Patients with DR and centre involving DMO with a central subfield thickness of > 400 microns, as determined using SD-OCT;
- >= 18 years of age
- Clear media and naïve to previous treatments for DMO.
Who cannot join
- Macular oedema related to other retinal disease
- Hazy media that prevents adequate retinal imaging
- Allergy to fluorescein
- Previous treatments for DMO
- DMO with central subfield thickness of < 400 microns
- Patients on systemic or topical steroids
Show all 16Show fewer
- Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- Treated with any other investigational medication or device within 60 days
- Pregnant women, women who have not yet reached the menopause (no menses for 12 months or more without an alternative medical cause) who test positive for pregnancy or who are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
- Men who have a female partner and who are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
- Female patients who are breastfeeding
- Active proliferative diabetic retinopathy (PDR) requiring treatment.
- Patients with other eye diseases besides DR
- Patients who are unable or unwilling to commit to the study schedule of events
- Serious illness that is likely to affect the patient's ability to complete the study
- Any patient showing a clinically significant improvement between the initial screening and presenting for the first screening/baseline visit may no longer be eligible for the study and will be recorded as a screen failure and will not be entered on to the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Belfast Health & Social Care Trust
Belfast, Co Antrim, BT12 6BA
About this study
Official title: A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema
ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.
Read the detailed description
Diabetic retinopathy a very most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR), both are complications of diabetes in the eye.
In DMO fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates the sight drops. The current treatments for DMO include laser and anti VEGF drugs and steroids. Anti VEGF drugs have been very helpful in the treatment of DMO. However, anti VEGF drugs need to be given by an injection into the eye, an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) will need to deliver this treatment to patients with DMO in the hospital.
Furthermore, patients require injections every four weeks during the first months of treatment and long term treatment is required. Moreover, not all patients respond to anti VEGFs: In 40% of patients the sight may not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
Given the above facts there appeared a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, it was thought that ARA 290 could potentially be helpful in treating patients with this condition. In light of this, the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO. If this treatment was successful, benefits may have included a reduction of the demands on health care services and patient benefits of: self administration of the drug at home by the patients; a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment (subcutaneous injection versus an injection into the eye).
- Conditions
- Diabetic Macular Oedema
- Being tested
- ARA290
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARA290Drug
Also called L-Pyroglutamyl-L-glutamyl-L-glutaminyl-L-leucyl-L-glutamyl-L-arginyl-L-alanyl-L-leucyl-L-asparaginyl-L-seryl-L-serine
4 mg subcutaneous injections of ARA290 over an 84 day period
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks. Receives: Drug: ARA290 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome - Best corrected distance visual acuity.
Best corrected distance visual acuity will be obtained in both eyes by a trained optometrist using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline and at week 12. The EDTRS total score will be recorded and used for the analysis.
Measured: From baseline to week 12 (+/- 7 days)
Secondary outcomes (12)
Secondary Outcome - Central subfield thickness
Central subfield retinal thickness (CST), as obtained in the central 1 mm area, will be determined by spectral domain optical coherence tomography (SD-OCT) and used for the analysis.
Measured: Changes from baseline to week 12 (+/- 7 days).
Secondary Outcome - Central retinal sensitivity
Retinal sensitivity will be determined by macular microperimetry in both eyes.
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Retinal perfusion
Retinal perfusion will be assessed by wide angle fundus fluorescein angiography (FFA).
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Tear production
The Schirmer test will be performed to measure tear production.
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Patient reported outcome
Patient reported outcomes will be evaluated by means of EQ-5D 5L questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable).
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in inflammatory markers
A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Number of Adverse events
Adverse events
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain
using Best corrected distance visual acuity
Measured: baseline to week 12
Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain
using Best corrected distance visual acuity
Measured: baseline to week 12
Secondary Outcome - Patient reported outcomes
Patient reported outcomes will be evaluated by means of NEI VFQ-25 questionnaires which will be administered to patients at baseline and at week 12 (and at week 16 if applicable).
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in glycosylated albumin
A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.
Measured: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in carbamylated albumin
A blood sample will be used to test for ARA 290 antibodies and to complete an exploratory analysis to determine levels of inflammatory markers and carbamylated and glycosylated albumin.
Measured: Changes from baseline to week 12 (+/- 7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2024
- Study startApr 2016
- Primary completion12 May 2017
- Study completionAug 2017
Why it stopped: Expiry of study drug - no replacement available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular OedemaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Araim Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Noemi Lois, Study chair, Belfast Health & Social Care Trust and Queen's University Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06626971
- Sponsor's protocol ID
- 14166NL-AS
- Acronym
- ARA290DMO
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2018
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema
- ClinicalTrials.gov ID
- NCT06626971
- Acronym / sponsor ID
- ARA290DMO / 14166NL-AS
- Conditions
- Diabetic Macular Oedema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Expiry of study drug - no replacement available.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Collaborators
- Araim Pharmaceuticals, Inc.
- Study start
- Apr 2016 (actual)
- Primary completion
- 12 May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 4 Oct 2024 (actual)
- 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.
ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.
Detailed description
Diabetic retinopathy a very most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR), both are complications of diabetes in the eye.
In DMO fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates the sight drops. The current treatments for DMO include laser and anti VEGF drugs and steroids. Anti VEGF drugs have been very helpful in the treatment of DMO. However, anti VEGF drugs need to be given by an injection into the eye, an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) will need to deliver this treatment to patients with DMO in the hospital.
Furthermore, patients require injections every four weeks during the first months of treatment and long term treatment is required. Moreover, not all patients respond to anti VEGFs: In 40% of patients the sight may not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
Given the above facts there appeared a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, it was thought that ARA 290 could potentially be helpful in treating patients with this condition. In light of this, the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO. If this treatment was successful, benefits may have included a reduction of the demands on health care services and patient benefits of: self administration of the drug at home by the patients; a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment (subcutaneous injection versus an injection into the eye).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Drug: ARA290Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with DR and centre involving DMO with a central subfield thickness of > 400 microns, as determined using SD-OCT;
- >= 18 years of age
- Clear media and naïve to previous treatments for DMO.
Key exclusion criteria (16 listed)
- Macular oedema related to other retinal disease
- Hazy media that prevents adequate retinal imaging
- Allergy to fluorescein
- Previous treatments for DMO
- DMO with central subfield thickness of < 400 microns
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 |
|---|---|---|
| ARA290Also: L-Pyroglutamyl-L-glutamyl-L-glutaminyl-L-leucyl-L-glutamyl-L-arginyl-L-alanyl-L-leucyl-L-asparaginyl-L-seryl-L-serine4 mg subcutaneous injections of ARA290 over an 84 day period | Drug | Intervention |
Primary outcome
Primary Outcome - Best corrected distance visual acuity.
Time frame: From baseline to week 12 (+/- 7 days)
Best corrected distance visual acuity will be obtained in both eyes by a trained optometrist using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline and at week 12. The EDTRS total score will be recorded and used for the analysis.
12 secondary outcomes
Secondary Outcome - Central subfield thickness
Time frame: Changes from baseline to week 12 (+/- 7 days).
Secondary Outcome - Central retinal sensitivity
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Retinal perfusion
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Tear production
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Patient reported outcome
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in inflammatory markers
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Number of Adverse events
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain
Time frame: baseline to week 12
Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain
Time frame: baseline to week 12
Secondary Outcome - Patient reported outcomes
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in glycosylated albumin
Time frame: Changes from baseline to week 12 (+/- 7 days)
Secondary Outcome - Change in carbamylated albumin
Time frame: Changes from baseline to week 12 (+/- 7 days)
Results and safety
The study was stopped early (reason given: Expiry of study drug - no replacement available.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Individual participant dataSharing planned: No
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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.
Noemi Lois study chair
Belfast Health & Social Care Trust and Queen's University Belfast
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ARA290 in people with Diabetic Macular Oedema, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
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 3 inclusion and 16 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 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study was stopped early (reason given: Expiry of study drug - no replacement available.). Results are not available in the source record.
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?
Primary Outcome - Best corrected distance visual acuity. (time frame: From baseline to week 12 (+/- 7 days)). 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 4 Oct 2024.