A Study of Denufosol Tetrasodium Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

A Randomized, Double-Masked, Parallel, Group, Multi-Center, Dose Ranging Pilot Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Post Cataract Extraction Macular Edema

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00135655

Enrollment

Registered

2005-08-26

Start date

2005-08-31

Completion date

Unknown

Last updated

2013-05-21

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

Conditions

Macular Edema, Cystoid

Keywords

macular edema, post cataract extraction, cystoid macular edema, post cataract extraction macular edema

Brief summary

The purpose of this study is to investigate the safety and tolerability of three dose strengths of the study drug in subjects with post cataract extraction macular edema.

Interventions

DRUGdenufosol tetrasodium (INS37217) Intravitreal Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have persistent post cataract extraction macular edema whose condition is stable * Have no change in medication regimen of immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents for a specified period of time prior to randomization * Have at least one eligible eye to be treated in the study * Have an optical coherence tomography (OCT) scan with a qualifying retinal thickness in the study eye * Have macular edema confirmed by fluorescein angiography

Exclusion criteria

* Have proliferative vitreoretinopathy greater than grade B in either eye * Have ocular disorders in the study eye that may confound interpretation of study results * Have ophthalmic disorders in the study eye that may influence final visual acuity and/or fluorescein angiography interpretation * Have had cataract surgery in the study eye in the past 2 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days * Have uncontrollable elevated intraocular pressure (IOP) or advanced glaucoma * Have had any periocular or intravitreal injection of corticosteroids in the study eye within 3 months * Have had any ocular implant device for the delivery of therapeutic agents * Be taking any excluded medications that could obscure or confound study results

Design outcomes

Primary

Measure	Time frame
safety	—
tolerability	—
retinal thickness	—
visual acuity	—

Outcome results

None listed

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