Macular DegenerationPhase 1/2NCT01749891
A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration
A Phase 1/2 study testing ALG 1001 in people with Macular Degeneration, run by Allegro Ophthalmics, LLC at 1 site in Mexico.
Trial summary
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Macular Degeneration
- What is being tested?
- ALG 1001
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteMexico
- Study dates
- Mar 2012to 7 Jun 2013
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, 50 years of age or older.
- Active wet macular degeneration (AMD).
- Subfoveal CNV (choroidal neovascular membrane) secondary to AMD in the study eye less than or equal to 12 MPS disc areas.
- CNV greater than 50% of lesion area.
- CNV may be classic, minimally classic, or occult.
- For minimally classic and occult lesions in the study eye, must demonstrate decrease in BCVA (best corrected visual acuity) that must be assessed based on clinical exploration, macular thickening, presence of subretinal fluid or hemorrhage, and/or OCT findings consistent with CNV.
Show all 13Show fewer
- Study eye has a BCVA of 20/50 to 20/320 ETDRS (Early Treatment Diabetic Retinopathy Study )equivalent (65 letters to 23 letters), which in the opinion of the investigator is primarily due to Wet AMD.
- Decrease in BCVA must be assessed based on clinical exploration, macular thickening, and/or fluorescein angiography consistent with CNV.
- Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm.
- Willing and able to return for all study visits.
- Able to meet the extensive post-op evaluation regimen.
- Patient can understand and sign informed consent form.
- If subject is a female less than 60 years old, negative pregnancy test during the screening window.
Who cannot join
- Media opacities or abnormalities that would preclude observation of the retina.
- Other retinal pathologies that would interfere with the patient's vision.
- Presence of other causes of CNV, including pathologic myopia, OHS (ocular histoplasmosis syndrome), angioid streaks, choroidal rupture or multifocal choroiditis in the study eye.
- RPE (retinal pigment epithelium) rip or tear in the study eye.
- Patients with current or prior retinal detachments, retinal tears, or tractional detachments in either eye.
- A history of cataract surgery complications/vitreous loss in the study eye.
Show all 17Show fewer
- A history of penetrating ocular trauma in the study eye.
- Chronic or recurrent uveitis.
- Has undergone a vitrectomy (anterior or pars plana) in the study eye.
- Ongoing ocular infection or inflammation in either eye.
- A history of intravitreal injections of any type in the study eye within the last 45 days prior to study enrollment.
- A history of cataract surgery complications/vitreous loss in the study eye.
- Congenital malformations in the study eye.
- Mentally handicapped.
- Pregnant or a nursing female.
- Currently participating in any other clinical research study
- Contraindication to the study medication.
Trial locations and contacts
1 site in 1 country.
About this study
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
Read the detailed description
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
The specific objective of this six-month study is to evaluate the safety and efficacy of three monthly ophthalmic intravitreal injections of ALG-1001 in human subjects with Wet AMD, and to follow these subjects for an additional four months off-treatment. Three cohorts have been established as part of the study design, utilizing three different doses.
- Conditions
- Macular Degeneration
- Being tested
- ALG 1001
- Keywords
- Age Related Wet Macular Degeneration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALG 1001Drug
Also called ALG-1001
Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1.5 mg ALG - 1001 | Experimental | Arm 1.5 mg ALG- 1001 per 50ul Receives: Drug: ALG 1001 |
| Arm 2.5 mg ALG -1001 | Experimental | Arm 2.5 mg ALG -1001 per 50ul Receives: Drug: ALG 1001 |
| Arm 4.0 mg ALG -1001 | Experimental | Arm 3 4.0 mg ALG -1001 per 50ul 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. The determination will be made by ocular adverse events by standard clinical ophthalmic evaluation, visual acuity changes at baseline by slit lamp biomicroscopy, tonometry, indirect ophthalmoscopy/ fundus photography, fluorescein angiography, OCT (optical coherence tomography) central macular thickness.
Measured: 6 months
Secondary outcomes (1)
Changes in OCT central macular thickness
Changes in OCT Central Macular Thickness
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 posted17 Dec 2012 (estimated)
- Study startMar 2012
- Primary completion4 Jun 2013
- Study completion7 Jun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DegenerationStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allegro Ophthalmics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jose L Guerrero-Narranjo, MD, Principal investigator, APEC Hospital Mexico City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01749891
- Sponsor's protocol ID
- Focus 3
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2012
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01749891
- Acronym / sponsor ID
- Focus 3
- Conditions
- Macular Degeneration
- Keywords
- Age Related Wet Macular Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Allegro Ophthalmics, LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- 4 Jun 2013 (actual)
- Study completion
- 7 Jun 2013 (actual)
- First posted
- 17 Dec 2012 (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 general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
Detailed description
The general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
The specific objective of this six-month study is to evaluate the safety and efficacy of three monthly ophthalmic intravitreal injections of ALG-1001 in human subjects with Wet AMD, and to follow these subjects for an additional four months off-treatment. Three cohorts have been established as part of the study design, utilizing three different doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1.5 mg ALG - 1001 | Experimental | Drug: ALG 1001Arm 1.5 mg ALG- 1001 per 50ul |
| Arm 2.5 mg ALG -1001 | Experimental | Drug: ALG 1001Arm 2.5 mg ALG -1001 per 50ul |
| Arm 4.0 mg ALG -1001 | Experimental | Drug: ALG 1001Arm 3 4.0 mg ALG -1001 per 50ul |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female subjects, 50 years of age or older.
- Active wet macular degeneration (AMD).
- Subfoveal CNV (choroidal neovascular membrane) secondary to AMD in the study eye less than or equal to 12 MPS disc areas.
- CNV greater than 50% of lesion area.
- CNV may be classic, minimally classic, or occult.
Key exclusion criteria (17 listed)
- Media opacities or abnormalities that would preclude observation of the retina.
- Other retinal pathologies that would interfere with the patient's vision.
- Presence of other causes of CNV, including pathologic myopia, OHS (ocular histoplasmosis syndrome), angioid streaks, choroidal rupture or multifocal choroiditis in the study eye.
- RPE (retinal pigment epithelium) rip or tear in the study eye.
- Patients with current or prior retinal detachments, retinal tears, or tractional detachments in either 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 |
|---|---|---|
| ALG 1001Also: ALG-1001Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution. | Drug | Arm 1.5 mg ALG - 1001, Arm 2.5 mg ALG -1001, Arm 4.0 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. The determination will be made by ocular adverse events by standard clinical ophthalmic evaluation, visual acuity changes at baseline by slit lamp biomicroscopy, tonometry, indirect ophthalmoscopy/ fundus photography, fluorescein angiography, OCT (optical coherence tomography) central macular thickness.
1 secondary outcome
Changes in OCT central macular thickness
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2017.
Related trials for Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
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 recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
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.
Jose L Guerrero-Narranjo, MD principal investigator
APEC Hospital Mexico City
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 Macular Degeneration, 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 13 inclusion and 17 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 15 Dec 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 15 Dec 2017.