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

Primary Purpose

Macular Degeneration

Status

Completed

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

ALG 1001

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring Age Related Wet Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
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.

Exclusion Criteria:

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.
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.

Sites / Locations

APEC Hospital La Ceguera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Arm 1.5 mg ALG - 1001

Arm 2.5 mg ALG -1001

Arm 4.0 mg ALG -1001

Arm Description

Arm 1.5 mg ALG- 1001 per 50ul

Arm 2.5 mg ALG -1001 per 50ul

Arm 3 4.0 mg ALG -1001 per 50ul

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in OCT central macular thickness

Changes in OCT Central Macular Thickness

Full Information

NCT ID

NCT01749891

First Posted

December 6, 2012

Last Updated

December 13, 2017

Sponsor

Allegro Ophthalmics, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01749891

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

June 4, 2013 (Actual)

Study Completion Date

June 7, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Allegro Ophthalmics, LLC

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Degeneration

Keywords

Age Related Wet Macular Degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1.5 mg ALG - 1001

Arm Type

Experimental

Arm Description

Arm 1.5 mg ALG- 1001 per 50ul

Arm Title

Arm 2.5 mg ALG -1001

Arm Type

Experimental

Arm Description

Arm 2.5 mg ALG -1001 per 50ul

Arm Title

Arm 4.0 mg ALG -1001

Arm Type

Experimental

Arm Description

Arm 3 4.0 mg ALG -1001 per 50ul

Intervention Type

Drug

Intervention Name(s)

ALG 1001

Other Intervention Name(s)

ALG-1001

Intervention Description

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.

Primary Outcome Measure Information:

Title

Observation of dose limiting toxicity.

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Changes in OCT central macular thickness

Description

Changes in OCT Central Macular Thickness

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. 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. Exclusion Criteria: 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. 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose L Guerrero-Narranjo, MD

Organizational Affiliation

APEC Hospital Mexico City

Official's Role

Principal Investigator

Facility Information:

Facility Name

APEC Hospital La Ceguera

City

Mexico City

Country

Mexico

12. IPD Sharing Statement

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

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