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Retinal Vein OcclusionPhase 1/2RELATENCT01003106

Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

A Phase 1/2 study testing Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly) and Pro re nata (prn) ranibizumab in people with Retinal Vein Occlusion, run by Peter A Campochiaro, MD 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 study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Retinal Vein Occlusion
What is being tested?
Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly) and Pro re nata (prn) ranibizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
81 participants
Where
1 siteUnited States
Study dates
Nov 2009to Apr 2015
Phase
Phase 1/2
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed informed consent and authorization of use and disclosure of protected health information
  • Age equal to or greater than 18 years
  • Diagnosis of macular edema due to central or branch retinal vein occlusion
  • Foveal thickness of equal to or greater than 250 mm, as assessed by OCT
  • Best corrected visual acuity score in the study eye of 20/40 to 20/400 inclusive (Snellen equivalents using the ETDRS protocol at a distance of 4 meters). Only one eye will be treated in the study. If both eyes are eligible, the investigator will select the eye to be enrolled.
  • In the opinion of the investigator, decreased vision in the study eye is due to foveal thickening from vein occlusion and not from other obvious causes of decreased vision

Who cannot join

  • Scatter laser photocoagulation or macular photocoagulation within 3 months of study entry in the study eye
  • Intraocular surgery in the study eye within 3 months of study entry
  • Use of intraocular or periocular injection of steroids in the study eye (e.g., triamcinolone) within 4 months of study entry
  • Previous use of an anti-VEGF drug within 3 months of study entry
  • Cataract surgery in the study eye within 3 months of study entry; Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry; or any other intraocular surgery within 3 months preceding Day 0.
  • History of vitreoretinal surgery in the study eye within 3 months of study entry
Show all 15Show fewer
  • Uncontrolled glaucoma (defined as intraocular pressure ³30 mm Hg despite treatment with anti-glaucoma medications)
  • History of cerebral vascular accident, myocardial infarction, transient ischemic attacks within 3 months of study enrollment.
  • Pregnancy (positive pregnancy test) or lactation
  • Premenopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
  • Have the presence of active malignancy, including lymphoproliferative disorders. Subjects with a history of fully resolved basal or squamous cell skin cancer may be enrolled.
  • Any condition that the investigator believes would pose a significant hazard to the subject if investigational therapy were initiated.
  • History of allergy to humanized antibodies or any component of the ranibizumab formulation
  • Inability to comply with study or followup procedures
  • Participation in another simultaneous medical investigation or trial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Wilmer Eye Institute at Johns Hopkins University

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)

The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Read the detailed description

The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.

Being tested
Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly), Pro re nata (prn) ranibizumab, Pro re nata (prn) Laser photocoagulation
Keywords
RVO, BRVO, CRVO, Vein occlusion
Medical subject headings
Retinal Vein Occlusion

What participants receive

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

  • Ranibizumab 0.5mg (monthly)Drug

    Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone

  • Ranibizumab 2.0mg (monthly)Drug

  • Pro re nata (prn) ranibizumabDrug

  • Pro re nata (prn) Laser photocoagulationProcedure or surgery

Study groups in NCT01003106
Study groupRoleWhat they receive
BRVO- Ranibizumab 0.5mg aloneExperimentalBranch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
Receives: Drug: Ranibizumab 0.5mg (monthly)
BRVO- Pro re nata (prn) ranibizumab with laserExperimentalBranch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
Receives: Drug: Pro re nata (prn) ranibizumab; Procedure: Pro re nata (prn) Laser photocoagulation
BRVO- Ranibizumab 2.0mg aloneExperimentalBranch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Receives: Drug: Ranibizumab 2.0mg (monthly)
BRVO- Pro re nata (prn) ranibizumabExperimentalBranch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Receives: Drug: Pro re nata (prn) ranibizumab
CRVO- Ranibizumab 0.5mg aloneExperimentalCentral retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
Receives: Drug: Ranibizumab 0.5mg (monthly)
CRVO- Pro re nata (prn) ranibizumab with laserExperimentalCentral retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
Receives: Drug: Pro re nata (prn) ranibizumab; Procedure: Pro re nata (prn) Laser photocoagulation
CRVO- Ranibizumab 2.0mg aloneExperimentalCentral retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
Receives: Drug: Ranibizumab 2.0mg (monthly)
CRVO- Pro re nata (prn) ranibizumabExperimentalCentral retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
Receives: Drug: Pro re nata (prn) ranibizumab

What is being measured

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

  1. Incidence and Severity of Ocular and Non-ocular Adverse Events.

    Measured: 36 months

Secondary outcomes (4)

  1. Mean Change From Baseline to Month 6 in Best Corrected Visual Acuity in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab

    Measured: Baseline to month 6

  2. Mean Change From Month 6 to Month 36 in Best Corrected Visual Acuity in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.

    Measured: Month 6- Month 36

  3. Mean Change From Baseline to Month 6 in Central Subfield Thickness in Patients Treated With 0.5mg Versus 2.0mg of Ranibizumab

    Measured: Baseline to month 6

  4. Mean Change From Month 6 to Month 36 in Central Subfield Thickness in Patients Treated With Prn Ranibizumab+Laser Photocoagulation Versus Prn Ranibizumab Alone.

    Measured: Month 6- Month 36

Timeline

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

  1. First posted28 Oct 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionApr 2015
  4. Study completionApr 2015

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01003106
Sponsor's protocol ID
NA_00032394
Acronym
RELATE
Status last verified
Feb 2016
First submitted
26 Oct 2009
Last updated
15 Mar 2016
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ranibizumab 0.5mg (monthly), Ranibizumab 2.0mg (monthly) and Pro re nata (prn) ranibizumab in people with Retinal Vein Occlusion, run by Peter A Campochiaro, MD 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 6 inclusion and 15 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 15 Mar 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

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 15 Mar 2016). 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?

Incidence and Severity of Ocular and Non-ocular Adverse Events. (time frame: 36 months). 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 NCT01003106.

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 15 Mar 2016.

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