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

Study Overview
=================
Brief 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). 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.

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

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: ALG 1001


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1.5 mg ALG - 1001<br>Arm 1.5 mg ALG- 1001 per 50ul | Drug: ALG 1001<br>* 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.<br>* Other names: ALG-1001;|
| Experimental: Arm 2.5 mg ALG -1001<br>Arm 2.5 mg ALG -1001 per 50ul | Drug: ALG 1001<br>* 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.<br>* Other names: ALG-1001;|
| Experimental: Arm 4.0 mg ALG -1001<br>Arm 3 4.0 mg ALG -1001 per 50ul | Drug: ALG 1001<br>* 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.<br>* 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age Related Wet Macular Degeneration