Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Retinopathy Iris Neovascularization

Keywords

VEGFiris neovascularizationdiabetic retinopathyMacugen

Outcome Measures

Primary Outcomes (1)

Regression of iris neovascularization and prevention of development of neovascular glaucoma
prospective

Secondary Outcomes (6)

Iris angiogram - conducted at screening/treatment visit,week 1, week 3, week 6, week 9, week 12, week 15, week 18, and week 52.
prospective
Regression will be determined by lack of leakage and/or lack of flow through the abnormal vessels.
prospective
Assessment of retina with dilated fundus examination for signs of neovascularization in posterior segment at each follow-up visit
prospective
The complete resolution of iris neovascularization, or regression to less than 2 clock hours of iris neovascularization.
prospective
A clinically significant reduction in the clock hours of angle neovascularization.
prospective
+1 more secondary outcomes

Study Arms (2)

1

ACTIVE COMPARATOR

Panretinal Photocoagulation (PRP)

Procedure: Panretinal Photocoagulation (PRP)

2

ACTIVE COMPARATOR

Panretinal Photocoagulation and Macugen Intravitreal Injection

Other: Pegaptanib Sodium Injection/Panretinal Photocoagulation

Interventions

Pegaptanib Sodium Injection/Panretinal PhotocoagulationOther

Pegaptanib Sodium Injection is a single dose prefilled syringe and is formulated as a 3.47 mg/mL solution. Combined with an ocular laser procedure.

Also known as: Macugen

Panretinal Photocoagulation (PRP)Procedure

Ocular Laser Procedure

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, at least 18 years of age
Diabetic retinopathy with iris neovascularization

Sponsors & Collaborators

Hermann Eye Center
Otherlead
Eyetech Pharmaceuticals
Industrycollaborator

Study Sites (1)

Robert Cizik Eye Clinic

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

pegaptanib

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

Robert M Feldman, MD
Hermann Eye Fund & University of Texas -- Houston
PRINCIPAL INVESTIGATOR

Enrollment

10 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER

Study Record Dates

First Submitted

February 22, 2006

First Posted

February 24, 2006

Study Start

January 2006

Date type not reported

This date has not been verified as actual or estimated.

A Pilot Study for the Treatment of Iris Neovascularization With Macugen

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (6)

Study Arms (2)

1

2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations