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Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status

Withdrawn

Phase

Phase 1

Locations

Mexico

Study Type

Interventional

Intervention

ALG-1001

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema

Eligibility Criteria

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

Inclusion Criteria:

Male or female subjects, 18 years of age or older.
Patient (male or female) with active diabetic macular edema (DME).
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.
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.
Patients Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm
Patient is willing and able to return for all study visits.
Patient is able to meet the extensive post-op evaluation regimen
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.

Sites / Locations

Apec Hospital La Ceguera

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm 1.5 mg ALG-1001

Arm 2.5 mg ALG-1001

Arm 5.0 mg ALG-1001

Arm 7.5 mg ALG-1001

Arm Description

Group Using 1.5 mg per 100 ul of ALG-1001

Group Using 2.5 mg per 100 ul of ALG-1001

Group Using 5.0 mg per 100 ul of ALG-1001

Group Using 7.5 mg per 100 ul of ALG-1001

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. 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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT01482871

First Posted

November 28, 2011

Last Updated

December 6, 2012

Sponsor

Allegro Ophthalmics, LLC

1. Study Identification

Unique Protocol Identification Number

NCT01482871

Brief Title

Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

Official Title

Safety Study of ALG 1001 to Treat Diabetic Macular Edema

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Withdrawn

Study Start Date

January 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (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

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.

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.

6. Conditions and Keywords

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

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

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

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1.5 mg ALG-1001

Arm Type

Experimental

Arm Description

Group Using 1.5 mg per 100 ul of ALG-1001

Arm Title

Arm 2.5 mg ALG-1001

Arm Type

Experimental

Arm Description

Group Using 2.5 mg per 100 ul of ALG-1001

Arm Title

Arm 5.0 mg ALG-1001

Arm Type

Experimental

Arm Description

Group Using 5.0 mg per 100 ul of ALG-1001

Arm Title

Arm 7.5 mg ALG-1001

Arm Type

Experimental

Arm Description

Group Using 7.5 mg per 100 ul of ALG-1001

Intervention Type

Drug

Intervention Name(s)

ALG-1001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ALG-1001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ALG-1001

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

ALG-1001

Intervention Description

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

Primary Outcome Measure Information:

Title

Observation of dose limiting toxicity

Description

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Improvements in BCVA ETDRS

Description

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female subjects, 18 years of age or older. Patient (male or female) with active diabetic macular edema (DME). 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. 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. Patients Intra-Ocular Pressure (IOP) is under control, IOP ≤ 25 mm Patient is willing and able to return for all study visits. Patient is able to meet the extensive post-op evaluation regimen 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hugo Quiroz, M.D

Organizational Affiliation

Denver Medical Hospital

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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Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

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