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

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: 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.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • APEC Hospital La Ceguera

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: ALG-1001

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in OCT central macular thickness	Changes in OCT Central Macular Thickness	6 months

Collaborators and Investigators

• Sponsor: Allegro Ophthalmics, LLC
• Investigators: Principal Investigator: Jose L Guerrero-Narranjo, MD, APEC Hospital Mexico City

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): June 4, 2013
• Study Completion (Actual): June 7, 2013

Study Registration Dates

• First Submitted: December 6, 2012
• First Submitted That Met QC Criteria: December 12, 2012
• First Posted (Estimate): December 17, 2012

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 13, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Age Related Wet Macular Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: Focus 3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No