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Safety Study of ALG- 1001 to Treat Diabetic Macular Edema

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier:
NCT01482871
First received: November 28, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetic Macular Edema
 Drug: ALG-1001
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Study of ALG 1001 to Treat Diabetic Macular Edema

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Allegro Ophthalmics, LLC:

Primary Outcome Measures:
  • Observation of dose limiting toxicity [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 0
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Arm 2.5 mg ALG-1001
Group Using 2.5 mg per 100 ul of ALG-1001
 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
Experimental: Arm 5.0 mg ALG-1001
Group Using 5.0 mg per 100 ul of ALG-1001
 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
Experimental: Arm 7.5 mg ALG-1001
Group Using 7.5 mg per 100 ul of ALG-1001
 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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482871

Locations
Mexico
Apec Hospital La Ceguera
Mexico City, Mexico
Sponsors and Collaborators
Allegro Ophthalmics, LLC
Investigators
Principal Investigator: Hugo Quiroz, M.D Denver Medical Hospital
  More Information

No publications provided

Responsible Party: Allegro Ophthalmics, LLC
ClinicalTrials.gov Identifier: NCT01482871     History of Changes
Other Study ID Numbers: Focus 2
Study First Received: November 28, 2011
Last Updated: December 6, 2012
Health Authority: Mexico: Ministry of Health

Keywords provided by Allegro Ophthalmics, LLC:
Diabetic Macular Edema

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on June 17, 2013