Diabetic Macular EdemaPhase 1/2NCT01482871
Safety Study of ALG- 1001 to Treat Diabetic Macular Edema
A Phase 1/2 study testing ALG-1001 in people with Diabetic Macular Edema, run by Allegro Ophthalmics, LLC at 1 site in Mexico.
Trial summary
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. 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?
- ALG-1001
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2011to Nov 2011
- Phase
- Phase 1/2
- 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
- Male or female subjects, 18 years of age or older.
- Patient (male or female) with active diabetic macular edema (DME).
- Patient whose study eye has a best corrected visual acuity (BCVA) of 20/50 to 20/160 ETDRS equivalent (65 letters to 36 letters), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 1.5mg/100µl or 2.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
- Patient whose study eye has a best corrected visual acuity (BCVA) of 20/200 or worse ETDRS equivalent (35 letters or less), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 5.0mg/100µl or 7.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
- Patients Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm
- Patient is willing and able to return for all study visits.
- Patient is able to meet the extensive post-op evaluation regimen
- Patient can understand and sign Informed Consent form.
Who cannot join
- 1. Patients with Media Opacities or abnormalities that would preclude observation of the Retina.
- 2. Patients with active Proliferative Diabetic Retinopathy (PDR) in the study eye such as NVE, NVD, Vitreous Hemorrhage, or Neovascular Glaucoma.
- 3. Patients with current or prior Retinal Detachments, Retinal tears, or Tractional Detachments in either eye.
- 4. Patients with significant epiretinal membranes determined by the investigator to be contributing to the macular edema.
- 5. Patients with other retinal pathologies that would interfere with their vision.
- 6. Patient that has Chronic or Recurrent Uveitis. 7. Patient that has undergone Vitrectomy (anterior or pars plana) in the study eye.
Show all 11Show fewer
- 8. Patient has ongoing Ocular infection or inflammation in either eye. 9. Patient has a history of intravitreal injections of any type in the study eye within the last 45 days prior to study enrollment.
- 10. Patient has a history of focal laser of any type in the study eye within the last 90 days prior to study enrollment.
- 11. Patient has a history of cataract surgery complications/vitreous loss in the study eye.
- 12. Patient has congenital eye malformations in the study eye. 13. Patient has a history of penetrating Ocular Trauma in the study eye. 14. Patient is mentally handicapped. 15. Patient is Pregnant or Nursing female. If subject is 18 to 60 years old. Negative pregnancy test during the screening window.
- 16. Patient that is currently participating in any other Clinical Research Study 17. Patient has contraindication to the study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety Study of ALG 1001 to Treat Diabetic Macular Edema
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters) and OCT central macular thickness.
Read the detailed description
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in best corrected visual acuity (BCVA) (ETDRS letters) and OCT central macular thickness.
- Conditions
- Diabetic Macular Edema
- Being tested
- ALG-1001
- Keywords
- Diabetic Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALG-1001Drug
1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
ALG-1001Drug
2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
ALG-1001Drug
5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
ALG-1001Drug
7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
| Study group | Role | What they receive |
|---|---|---|
| Arm 1.5 mg ALG-1001 | Experimental | Group Using 1.5 mg per 100 ul of ALG-1001 Receives: Drug: ALG-1001 |
| Arm 2.5 mg ALG-1001 | Experimental | Group Using 2.5 mg per 100 ul of ALG-1001 Receives: Drug: ALG-1001 |
| Arm 5.0 mg ALG-1001 | Experimental | Group Using 5.0 mg per 100 ul of ALG-1001 Receives: Drug: ALG-1001 |
| Arm 7.5 mg ALG-1001 | Experimental | Group Using 7.5 mg per 100 ul of ALG-1001 Receives: Drug: ALG-1001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observation of dose limiting toxicity
The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. This determination will be made by the following criteria : Ocular Adverse Events by standard Clinical Ophthalmic examination Visual acuity changes from BCVA (ETDRS equivalent) at baseline by Slit Lamp Bio-microscopy, Tonometry, Indirect Ophthalmoscopy/ Fundus Photography, Fluorescein Angiography, OCT Central Macular Thickness, and ERG Examination
Measured: 6 months
Secondary outcomes (1)
Improvements in BCVA ETDRS
Reduction in OCT central macular thickness in subjects with baseline diabetic macular edema and Improvements in BCVA ETDRS letters at 4 meters from baseline to 30 days, 60 days and 90 days post injection evaluations with safety evaluations to 180 days
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro Ophthalmics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hugo Quiroz, M.D, Principal investigator, Denver Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482871
- Sponsor's protocol ID
- Focus 2
- Status last verified
- Dec 2012
- First submitted
- 28 Nov 2011
- Last updated
- 7 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of ALG 1001 to Treat Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT01482871
- Acronym / sponsor ID
- Focus 2
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic Macular Edema
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Allegro Ophthalmics, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 1 Dec 2011 (estimated)
- 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.
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters) and OCT central macular thickness.
Detailed description
The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in best corrected visual acuity (BCVA) (ETDRS letters) and OCT central macular thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1.5 mg ALG-1001 | Experimental | Drug: ALG-1001Group Using 1.5 mg per 100 ul of ALG-1001 |
| Arm 2.5 mg ALG-1001 | Experimental | Drug: ALG-1001Group Using 2.5 mg per 100 ul of ALG-1001 |
| Arm 5.0 mg ALG-1001 | Experimental | Drug: ALG-1001Group Using 5.0 mg per 100 ul of ALG-1001 |
| Arm 7.5 mg ALG-1001 | Experimental | Drug: ALG-1001Group Using 7.5 mg per 100 ul of ALG-1001 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, 18 years of age or older.
- Patient (male or female) with active diabetic macular edema (DME).
- Patient whose study eye has a best corrected visual acuity (BCVA) of 20/50 to 20/160 ETDRS equivalent (65 letters to 36 letters), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 1.5mg/100µl or 2.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
- Patient whose study eye has a best corrected visual acuity (BCVA) of 20/200 or worse ETDRS equivalent (35 letters or less), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 5.0mg/100µl or 7.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
- Patients Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm
Key exclusion criteria (11 listed)
- 1. Patients with Media Opacities or abnormalities that would preclude observation of the Retina.
- 2. Patients with active Proliferative Diabetic Retinopathy (PDR) in the study eye such as NVE, NVD, Vitreous Hemorrhage, or Neovascular Glaucoma.
- 3. Patients with current or prior Retinal Detachments, Retinal tears, or Tractional Detachments in either eye.
- 4. Patients with significant epiretinal membranes determined by the investigator to be contributing to the macular edema.
- 5. Patients with other retinal pathologies that would interfere with their vision.
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 |
|---|---|---|
| ALG-10011.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops | Drug | Arm 1.5 mg ALG-1001 |
| ALG-10012.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops | Drug | Arm 2.5 mg ALG-1001 |
| ALG-10015.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops | Drug | Arm 5.0 mg ALG-1001 |
| ALG-10017.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops | Drug | Arm 7.5 mg ALG-1001 |
Primary outcome
Observation of dose limiting toxicity
Time frame: 6 months
The primary endpoint of this study is observation of dose limiting toxicity and the maximum tolerated dose. This determination will be made by the following criteria : Ocular Adverse Events by standard Clinical Ophthalmic examination Visual acuity changes from BCVA (ETDRS equivalent) at baseline by Slit Lamp Bio-microscopy, Tonometry, Indirect Ophthalmoscopy/ Fundus Photography, Fluorescein Angiography, OCT Central Macular Thickness, and ERG Examination
1 secondary outcome
Improvements in BCVA ETDRS
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2012.
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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.
Hugo Quiroz, M.D principal investigator
Denver Medical Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ALG-1001 in people with Diabetic Macular Edema, run by Allegro Ophthalmics, LLC at 1 site in Mexico.
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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Dec 2012. 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 Mexico. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 withdrawn before enrolling participants, so there are no results.
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?
Observation of dose limiting toxicity (time frame: 6 months). 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 7 Dec 2012.