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A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Allegro Ophthalmics, LLC
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier:
NCT01749891
First received: December 6, 2012
Last updated: December 12, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Macular Degeneration
Drug: ALG 1001
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Allegro Ophthalmics, LLC:

Primary Outcome Measures:
  • Observation of dose limiting toxicity. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Changes in OCT central macular thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Changes in OCT Central Macular Thickness


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1.5 mg ALG - 1001
Arm 1.5 mg ALG- 1001 per 50ul
Drug: 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 Name: ALG-1001
Experimental: Arm 2.5 mg ALG -1001
Arm 2.5 mg ALG -1001 per 50ul
Drug: 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 Name: ALG-1001
Experimental: Arm 4.0 mg ALG -1001
Arm 3 4.0 mg ALG -1001 per 50ul
Drug: 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 Name: ALG-1001

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female subjects, 50 years of age or older.
  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:

  1. Media opacities or abnormalities that would preclude observation of the retina.
  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01749891

Contacts
Contact: Vicken Karageozian, MD 949-940-8130 vkarageozian@allegroeye.com

Locations
Mexico
APEC Hospital La Ceguera Recruiting
Mexico City, Mexico
Contact: Jose L Gurerrero- Narranjo, MD       guenarmx@yahoo.com.mx   
Principal Investigator: Jose L Guerrero- Narranjo, MD         
Sponsors and Collaborators
Allegro Ophthalmics, LLC
Investigators
Principal Investigator: Jose L Guerrero-Narranjo, MD APEC Hospital Mexico City
  More Information

No publications provided

Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT01749891     History of Changes
Other Study ID Numbers: Focus 3
Study First Received: December 6, 2012
Last Updated: December 12, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Allegro Ophthalmics, LLC:
Age Related Wet Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014