Eales' DiseasePhase 2/3NCT00384449

Lucentis (Ranibizumab) for Eales' Disease

A Phase 2/3 study testing Ranibizumab in people with Eales' Disease, run by Oregon Health and Science University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary objective of this protocol is to look at whether Lucentis (ranibizumab) is safe and effective when used for macular edema (retinal swelling) due to Eales' disease. The secondary objective is to see if macular edema comes back within three months after the last dose of study drug is given. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Eales' Disease
What is being tested?: Ranibizumab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Oct 2006to Apr 2009
Phase: Phase 2/3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 21 years.
Disease related considerations:
For both treatment naïve and previously treated patients:
exclusion of all other causes of cystoid macular edema and retinal nonperfusion including branch or central vein occlusion, diabetic retinopathy, sickle retinopathy, sarcoidosis, systemic lupus and other collagen vascular diseases
chronic cystoid macular edema as noted clinically and on OCT 3 testing with persistent loss of visual acuity for 3 months or longer

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if the eye has received prior treatment (including laser photocoagulation and steroids) a 30 day washout period will be required prior to treatment with Lucentis.
BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.
OCT 3 central subfield > or = 250 on 2 separate readings in the central subfield.
Only one eye will be assessed in the study. If both eyes are eligible, the investigator will determine which eye will be entered into the study.

Who cannot join

Treatment for macular edema with intravitreal steroid or macugen within 30 days prior to enrollment in this study.
Previous vitrectomy within the past 6 months.
Previous cataract surgery within the preceding 12 months.
Active intraocular inflammation in the study eye.
Current vitreous hemorrhage in the study eye.
Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.

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A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
Participation in an investigational trial within 30 days of randomization that involved.
Treatment with any drug that has not received regulatory approval at the time of study entry.
Known allergy to any component of the study drug.
Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months. Major surgery is defined as a surgical procedure that is more extensive than fine needle biopsy/aspiration, placement of a central venous access device, removal/biopsy of a skin lesion, or placement of a peripheral venous catheter.
Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
Systemic anti-VEGF or pro-VEGF treatment within 3 months prior to randomization.
Systemic anti-VEGF or pro-VEGF treatment used during the 6 months of the study.
Current treatment for active systemic infection.
History of recurrent significant infections or bacterial infections.
Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the 6 months of the study.
Subjects meeting any of the following criteria will be excluded from the study:
Pregnancy (positive pregnancy test).
Prior enrollment in the study.
Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated.
Participation in another simultaneous medical investigation or trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Casey Eye Institute
Portland, Oregon, 97239

Other trials in United States

About this study

Official title: The Use of a VEGF Inhibitor (Lucentis) in Refractory Macular Edema Due to Eales' Disease

Read the detailed description

This is a six-month study. Eligible subjects will receive one injection of the study drug into one eye for each of three months. Visual acuity, blood pressure and eye pressure will be tested. Subjects' retinas will be examined and thickness measured by optical coherence tomography (OCT). Safety visits will be scheduled for the week after the injections. The investigators will monitor the subjects' eyes for infection and inflammation. After the three-month treatment period, subjects will return to the clinic monthly for four follow-up visits. Procedures and tests that will be performed at the follow-up visits include visual acuity, a retinal exam including OCT, blood pressure, and eye pressure.

Conditions: Eales' Disease
Being tested: Ranibizumab
Keywords: Eales
Medical subject headings: Eales disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RanibizumabDrug
Also called Lucentis
Consented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months

Study groups in NCT00384449
Study group	Role	What they receive
Lucentis (ranibizumab)	Experimental	Lucentis (ranibizumab) Receives: Drug: Ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in OCT Thickness.
Measured: Baseline and 6 months
Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)
Measured: Monthly through Month 6
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
No adverse events.
Measured: Monthly through Month 6

Secondary outcomes (2)

BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters.
Measured: Months 3,4,5 and 6
Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.
No adverse events.
Measured: Monthly through Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2006Apr 2009

First posted6 Oct 2006 (estimated)
Study startOct 2006
Primary completionApr 2009
Study completionApr 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Eales' DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2/3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00384449
Sponsor's protocol ID: FVF3849s
Status last verified: Jun 2019
First submitted: 5 Oct 2006
Last updated: 11 Jun 2019
Results posted: Yes, on ClinicalTrials.gov

Publications

Gupta SR, Flaxel CJ. The use of a vascular endothelial growth factor inhibitor (ranibizumab) in macular edema due to eales disease. Retin Cases Brief Rep. 2012 Winter;6(1):122-4. doi: 10.1097/ICB.0b013e31821608e8.
PubMed 25390730

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of a VEGF Inhibitor (Lucentis) in Refractory Macular Edema Due to Eales' Disease
ClinicalTrials.gov ID: NCT00384449
Acronym / sponsor ID: FVF3849s
Conditions: Eales' Disease
Keywords: Eales
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Oregon Health and Science UniversityUniversity, hospital or other
Collaborators: Genentech, Inc.
Study start: Oct 2006
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 6 Oct 2006 (estimated)
Results: Posted 11 Jun 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Lucentis (ranibizumab)	Experimental	Drug: RanibizumabLucentis (ranibizumab)

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 21 years.
Disease related considerations:
For both treatment naïve and previously treated patients:
BCVA using ETDRS charts of 20/40 to 20/400 (Snellen equivalent) in the study eye.

Key exclusion criteria (24 listed)

Treatment for macular edema with intravitreal steroid or macugen within 30 days prior to enrollment in this study.
Previous vitrectomy within the past 6 months.
Previous cataract surgery within the preceding 12 months.
Active intraocular inflammation in the study eye.
Current vitreous hemorrhage in the study eye.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RanibizumabAlso: LucentisConsented, enrolled subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered once a month for 3 months	Drug	Lucentis (ranibizumab)

Primary outcome

Change in OCT Thickness.
Time frame: Baseline and 6 months
Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)
Time frame: Monthly through Month 6
Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs
Time frame: Monthly through Month 6
No adverse events.

2 secondary outcomes

BCVA, as Assessed by the Number of Letters Read Correctly on the ETDRS Eye Chart at a Starting Test Distance of 4 Meters.
Time frame: Months 3,4,5 and 6
Incidence of Ocular and Non-ocular Adverse Events Evaluated Through Month 6.
Time frame: Monthly through Month 6

Results and safety

Results posted to the registry on 11 Jun 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lucentis (Ranibizumab)	1	1

Primary outcome: Change in OCT Thickness.

Time frame: Baseline and 6 months. Number. Unit: um

Measure	Lucentis (Ranibizumab) n = 1
Baseline, Day 0	269
Month 6	262

Population analysed: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

Primary outcome: Incidence and Severity of Ocular Adverse Events, as Identified by Eye Examination (Including Visual Acuity Testing)

Time frame: Monthly through Month 6. Number. Unit: adverse events

Measure	Lucentis (Ranibizumab) n = 1
Value	0

Population analysed: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

Primary outcome: Incidence and Severity of Other Adverse Events, as Identified by Physical Examination, Subject Reporting, and Changes in Vital Signs

Time frame: Monthly through Month 6. Number. Unit: adverse events

Measure	Lucentis (Ranibizumab) n = 1
Value	0

Population analysed: A patient was enrolled, but then became ineligible. The same patient was later re-enrolled and maintained eligibility.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Lucentis (Ranibizumab)	0 of 1 (0%)	0 of 1 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 25390730Gupta SR, Flaxel CJ. The use of a vascular endothelial growth factor inhibitor (ranibizumab) in macular edema due to eales disease. Retin Cases Brief Rep. 2012 Winter;6(1):122-4. doi: 10.1097/ICB.0b013e31821608e8.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Christina J. Flaxel, MD principal investigator

Casey Eye Institute, Oregon Health & Science University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Ranibizumab in people with Eales' Disease, run by Oregon Health and Science University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in OCT Thickness. (time frame: Baseline and 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00384449, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2019.