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

NCT01749891 | Completed Phase 1 DMC

• 1 other identifier: Focus 3
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

Age Related Wet Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in OCT central macular thickness

  6 months

Study Arms (3)

Arm 1.5 mg ALG - 1001

EXPERIMENTAL

Arm 1.5 mg ALG- 1001 per 50ul

Drug: ALG 1001

Arm 2.5 mg ALG -1001

EXPERIMENTAL

Arm 2.5 mg ALG -1001 per 50ul

Drug: ALG 1001

Arm 4.0 mg ALG -1001

EXPERIMENTAL

Arm 3 4.0 mg ALG -1001 per 50ul

Drug: ALG 1001

Interventions

ALG 1001 DRUG

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.

Also known as: ALG-1001

Arm 1.5 mg ALG - 1001; Arm 2.5 mg ALG -1001; Arm 4.0 mg ALG -1001

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allegro Ophthalmics, LLC: lead

Study Sites (1)

APEC Hospital La Ceguera

Mexico City, Mexico

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

risuteganib

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jose L Guerrero-Narranjo, MD

  APEC Hospital Mexico City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: December 17, 2012
• Study Start: March 1, 2012
• Primary Completion: June 4, 2013
• Study Completion: June 7, 2013
• Last Updated: December 15, 2017

Record last verified: 2017-12

Locations

ME (1)