A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration
NCT ID: NCT01749891
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2012-03-31
2013-06-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1.5 mg ALG - 1001
Arm 1.5 mg ALG- 1001 per 50ul
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.
Arm 2.5 mg ALG -1001
Arm 2.5 mg ALG -1001 per 50ul
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.
Arm 4.0 mg ALG -1001
Arm 3 4.0 mg ALG -1001 per 50ul
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Active wet macular degeneration (AMD).
3. Subfoveal CNV (choroidal neovascular membrane) secondary to AMD in the study eye less than or equal to 12 MPS disc areas.
4. CNV greater than 50% of lesion area.
5. CNV may be classic, minimally classic, or occult.
6. 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.
7. 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.
8. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, and/or fluorescein angiography consistent with CNV.
9. Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm.
10. Willing and able to return for all study visits.
11. Able to meet the extensive post-op evaluation regimen.
12. Patient can understand and sign informed consent form.
13. If subject is a female less than 60 years old, negative pregnancy test during the screening window.
Exclusion Criteria
2. Other retinal pathologies that would interfere with the patient's vision.
3. Presence of other causes of CNV, including pathologic myopia, OHS (ocular histoplasmosis syndrome), angioid streaks, choroidal rupture or multifocal choroiditis in the study eye.
4. RPE (retinal pigment epithelium) rip or tear in the study eye.
5. Patients with current or prior retinal detachments, retinal tears, or tractional detachments in either eye.
6. A history of cataract surgery complications/vitreous loss in the study eye.
7. A history of penetrating ocular trauma in the study eye.
8. Chronic or recurrent uveitis.
9. Has undergone a vitrectomy (anterior or pars plana) in the study eye.
10. Ongoing ocular infection or inflammation in either eye.
11. A history of intravitreal injections of any type in the study eye within the last 45 days prior to study enrollment.
12. A history of cataract surgery complications/vitreous loss in the study eye.
13. Congenital malformations in the study eye.
14. Mentally handicapped.
15. Pregnant or a nursing female.
16. Currently participating in any other clinical research study
17. Contraindication to the study medication.
50 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Allegro Ophthalmics, LLC
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jose L Guerrero-Narranjo, MD
Role: PRINCIPAL_INVESTIGATOR
APEC Hospital Mexico City
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
APEC Hospital La Ceguera
Mexico City, , Mexico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Focus 3
Identifier Type: -
Identifier Source: org_study_id