NCT00665106

Brief Summary

Evaluation of safety and tolerability of a single injection of NOVA63035 "Corticosteroid" administered at one of four doses in patients with diabetic macular edema (DME) secondary to diabetic retinopathy

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Apr 2008

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 23, 2008

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

May 27, 2015

Status Verified

May 1, 2015

Enrollment Period

3.4 years

First QC Date

April 22, 2008

Last Update Submit

May 26, 2015

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edemaDiabetesDiabetic retinopathy

Outcome Measures

Primary Outcomes (1)

  • Ocular safety

    Over one year

Study Arms (4)

cohort 1

EXPERIMENTAL

5 up to 6 patients per arm. Emulsion at 0.8% of drug product.

Drug: NOVA63035 "Corticosteroid"

cohort 2

EXPERIMENTAL

5 up to 6 patients per arm. Emulsion at 0.8% of drug product.

Drug: NOVA63035 "Corticosteroid"

cohort 3

EXPERIMENTAL

5 up to 6 patients per arm. Emulsion at 3.2% of drug product.

Drug: NOVA63035 "Corticosteroid"

cohort 4

EXPERIMENTAL

5 up to 6 patients per arm. Oily solution at 3.4% of drug product.

Drug: NOVA63035 "Corticosteroid"

Interventions

NOVA63035 "Corticosteroid"DRUG

Single injection in the study eye

cohort 1cohort 2cohort 3cohort 4

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • M \& F 18 years and older
  • Diagnosed with diabetes mellitus and presenting diabetic retinopathy

You may not qualify if:

  • Monocular
  • History of current ocular hypertension or glaucoma in either eye defined
  • Any significant ocular disease (other than diabetic retinopathy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

MeSH Terms

Conditions

Diabetes MellitusDiabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes Complications

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 23, 2008

Study Start

April 1, 2008

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

May 27, 2015

Record last verified: 2015-05

Locations

US(1)