Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

Safety Study of ALG 1001 to Treat Diabetic Macular Edema

The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in BCVA (ETDRS letters) and OCT central macular thickness.

Study Overview

• Status: Withdrawn
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: ALG-1001; Drug: ALG-1001; Drug: ALG-1001; Drug: ALG-1001

Detailed Description

The objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injection of ALG - 1001 in human subjects with diabetic macular edema. The primary endpoint of this study is observation of dose limiting toxicity and maximum tolerated dose. The secondary endpoint of this study is observation of a clinical effect in best corrected visual acuity (BCVA) (ETDRS letters) and OCT central macular thickness.

• Study Type: Interventional
• 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: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female subjects, 18 years of age or older.
2. Patient (male or female) with active diabetic macular edema (DME).
3. Patient whose study eye has a best corrected visual acuity (BCVA) of 20/50 to 20/160 ETDRS equivalent (65 letters to 36 letters), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 1.5mg/100µl or 2.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
4. Patient whose study eye has a best corrected visual acuity (BCVA) of 20/200 or worse ETDRS equivalent (35 letters or less), that in the opinion of the investigator is primarily due to DME will be intravitreally injected with 0.10 cc containing 5.0mg/100µl or 7.5mg/100µl of ALG-1001. Decrease in BCVA must be assessed based on clinical exploration, macular thickening, presence of clinical significant macular edema and/or OCT findings consistent with diabetic macular edema.
5. Patients Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm
6. Patient is willing and able to return for all study visits.
7. Patient is able to meet the extensive post-op evaluation regimen
8. Patient can understand and sign Informed Consent form.

Exclusion Criteria:

• 1. Patients with Media Opacities or abnormalities that would preclude observation of the Retina.

  2. Patients with active Proliferative Diabetic Retinopathy (PDR) in the study eye such as NVE, NVD, Vitreous Hemorrhage, or Neovascular Glaucoma.

  3. Patients with current or prior Retinal Detachments, Retinal tears, or Tractional Detachments in either eye.

  4. Patients with significant epiretinal membranes determined by the investigator to be contributing to the macular edema.

  5. Patients with other retinal pathologies that would interfere with their vision.

  6. Patient that has Chronic or Recurrent Uveitis. 7. Patient that has undergone Vitrectomy (anterior or pars plana) in the study eye.

  8. Patient has ongoing Ocular infection or inflammation in either eye. 9. Patient has a history of intravitreal injections of any type in the study eye within the last 45 days prior to study enrollment.

  10. Patient has a history of focal laser of any type in the study eye within the last 90 days prior to study enrollment.

  11. Patient has a history of cataract surgery complications/vitreous loss in the study eye.

  12. Patient has congenital eye malformations in the study eye. 13. Patient has a history of penetrating Ocular Trauma in the study eye. 14. Patient is mentally handicapped. 15. Patient is Pregnant or Nursing female. If subject is 18 to 60 years old. Negative pregnancy test during the screening window.

  16. Patient that is currently participating in any other Clinical Research Study 17. Patient has 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

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1.5 mg ALG-1001; Group Using 1.5 mg per 100 ul of ALG-1001	Drug: ALG-1001; 1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
Experimental: Arm 2.5 mg ALG-1001; Group Using 2.5 mg per 100 ul of ALG-1001	Drug: ALG-1001; 1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
Experimental: Arm 5.0 mg ALG-1001; Group Using 5.0 mg per 100 ul of ALG-1001	Drug: ALG-1001; 1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
Experimental: Arm 7.5 mg ALG-1001; Group Using 7.5 mg per 100 ul of ALG-1001	Drug: ALG-1001; 1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops; Drug: ALG-1001; 7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops

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. This determination will be made by the following criteria : Ocular Adverse Events by standard Clinical Ophthalmic examination Visual acuity changes from BCVA (ETDRS equivalent) at baseline by Slit Lamp Bio-microscopy, Tonometry, Indirect Ophthalmoscopy/ Fundus Photography, Fluorescein Angiography, OCT Central Macular Thickness, and ERG Examination	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvements in BCVA ETDRS	Reduction in OCT central macular thickness in subjects with baseline diabetic macular edema and Improvements in BCVA ETDRS letters at 4 meters from baseline to 30 days, 60 days and 90 days post injection evaluations with safety evaluations to 180 days	6 months

Collaborators and Investigators

• Sponsor: Allegro Ophthalmics, LLC
• Investigators: Principal Investigator: Hugo Quiroz, M.D, Denver Medical Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: November 28, 2011
• First Submitted That Met QC Criteria: November 29, 2011
• First Posted (Estimate): December 1, 2011

Study Record Updates

• Last Update Posted (Estimate): December 7, 2012
• Last Update Submitted That Met QC Criteria: December 6, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: Focus 2

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