Safety and Tolerability of NOVA63035 Corticosteroid in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

A Phase I, Open-Label, Dose-Escalation Clinical Study to Assess the Safety and Tolerability of NOVA63035 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00665106

Enrollment

Registered

2008-04-23

Start date

2008-04-30

Completion date

2011-09-30

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema, Diabetes, Diabetic retinopathy

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

Interventions

DRUGNOVA63035 Corticosteroid

Single injection in the study eye

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Ocular safety	Over one year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026