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Age-related Macular DegenerationPhase 1/2PREVENTNCT02140151

Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration

A Phase 1/2 study testing Ranibizumab 0.5mg in people with Age-related Macular Degeneration, run by Southern California Desert Retina Consultants, MC at 4 sites 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

This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD). Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-related Macular Degeneration
What is being tested?
Ranibizumab 0.5mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
4 sitesUnited States
Study dates
17 Sep 2014to 9 Jul 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

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 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult over 50 years old
  • Able to sign informed consent and comply with the study protocol for the duration of two years
  • Nonexudative age-related macular degeneration (AMD) in one eye (study eye)
  • History of exudative AMD in one eye only (fellow eye) diagnosed within 5 years of study enrollment

Who cannot join

  • Participation in another simultaneous medical investigation or clinical trial
  • Patient is pregnant, lactating, or premenopausal and not using adequate contraception
  • Known serious allergies to ranibizumab, fluorescein dye, drugs for pupillary dilation, topical anesthetic, sterilizing solution (e.g. Betadine solution)
  • Presence of ocular conditions with increased risk of choroidal neovascularization (CNVM) or pigment epithelial detachment (PED), including presumed ocular histoplasmosis syndrome (POHS), traumatic choroidal rupture, angioid streaks, pathologic myopia (spherical equivalent of ≥ -8 diopters or axial length of ≥ 25 mm), multifocal choroiditis, macular choroidal nevus, polypoidal choroidal vasculopathy (PCV), idiopathic central serous chorioretinopathy (ICSC), etc.
  • History of vitrectomy in the study eye
  • History of cataract surgery within 3 months of enrollment
Show all 15Show fewer
  • History of yttrium aluminum garnet (YAG) capsulotomy within 1 month of enrollment
  • History of intraocular or periocular corticosteroid therapy within the past 90 days
  • History of therapeutic radiation in the region of the study eye.
  • Presence of media opacity that would preclude adequate examination and/or imaging
  • Concurrent macular conditions that would affect the study parameters (epiretinal membrane, macular hole, macular edema) or require treatment within the duration of the study
  • Any progressive ocular condition (uncontrolled glaucoma, diabetic retinopathy, uveitis) that may affect the visual acuity for the duration of the study
  • Active ocular infection (i.e., bacterial, viral, parasitic, or fungal) in either eye at enrollment
  • Presence of any advanced systemic condition that may hinder the patients participation and completion of the study
  • Concurrent use of systemic anti-VEGF therapy

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Elman Retina

    Baltimore, Maryland, 21237

  • Northern California Retina Vitreous Associates

    Mountain View, California, 94040

  • Southern California Desert Retina Consultants

    Palm Desert, California, 92211

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota, 57701

Other trials in United States

About this study

Official title: Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration (AMD) in Vulnerable Eyes With Nonexudative AMD Trial: A Multicenter, Prospectively Randomized, Masked and Controlled, Interventional Investigator Sponsored Phase I/II Study

This study will determine whether quarterly injections of Ranibizumab may prevent eyes with dry age-related macular degeneration from progressing to wet age-related macular degeneration (AMD).

Read the detailed description

This is a multicenter, prospectively randomized, masked and controlled, interventional investigator sponsored phase I/II study of subjects with high-risk nonexudative age-related macular degeneration (AMD) treated with intravitreal ranibizumab quarterly for prophylaxis of conversion to exudative age-related macular degeneration.

The objective of this study is to investigate the safety and efficacy of prophylactic anti-vascular endothelial growth factor (VEGF) therapy with ranibizumab to prevent the development of exudative AMD in eyes with high-risk nonexudative AMD. In addition, baseline characteristics of high-risk eyes (fundus features, optical coherence tomography (OCT) parameters and genetic profile) will be evaluated to determine their predictive value in conversion to exudative AMD. The effect of ranibizumab on the atrophic component of AMD will also be monitored.

Being tested
Ranibizumab 0.5mg
Keywords
amd, non-exudative macular degeneration, exudative macular degeneration, age-related macular degeneration, ranibizumab, anti-VEGF
Medical subject headings
Macular Degeneration, Glycogen Storage Disease Type II, Wet Macular Degeneration

What participants receive

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

  • Ranibizumab 0.5mgDrug

    Also called Lucentis

Study groups in NCT02140151
Study groupRoleWhat they receive
ShamNo interventionSham Injection
Quarterly Ranibizumab 0.5mgActive comparatorQuarterly intravitreal injection of 0.5mg ranibizumab
Receives: Drug: Ranibizumab 0.5mg

What is being measured

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

  1. Development of exudative AMD

    Development of choroidal neovascularization (conversion) defined by the presence of leakage on fluorescein angiography (FA) and fluid within or below the retina or below the retinal pigment epithelium seen on spectral-domain optical coherence tomography (SD-OCT)

    Measured: 2 years

Secondary outcomes (7)

  1. Vision change

    Change in best-corrected visual acuity (BCVA) from baseline at 12 and 24 months

    Measured: 2 years

  2. Vision loss

    Proportion of eyes losing < 5, 10, and 15 letters on EDTRS chart at 12 and 24 months

    Measured: 2 years

  3. Number of injections

    Number of injections required in eyes that convert from dry to wet AMD during the study period

    Measured: 2 years

  4. Baseline predictive factors

    Baseline demographic, genetic and ocular characteristics predictive of development of wet AMD

    Measured: 2 years

  5. Development of geographic atrophy (GA)

    Development of geographic atrophy (GA) as detected by fundus photography (FP) and/or fundus autofluorescence (AF).

    Measured: 2 years

  6. Ocular adverse events

    Incidence and severity of ocular adverse events, as identified by eye examination and imaging

    Measured: 2 years

  7. Systemic adverse events

    Incidence and severity of other adverse events, as identified by physical examination or subject reporting.

    Measured: 2 years

Timeline

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

  1. First posted16 May 2014 (estimated)
  2. Study start17 Sep 2014
  3. Primary completion9 Jul 2020
  4. Study completion9 Jul 2020

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02140151
Sponsor's protocol ID
ML29258
Acronym
PREVENT
Status last verified
Aug 2022
First submitted
25 Apr 2014
Last updated
25 Aug 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Ranibizumab 0.5mg in people with Age-related Macular Degeneration, run by Southern California Desert Retina Consultants, MC at 4 sites 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 4 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 25 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Development of exudative AMD (time frame: 2 years). 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 NCT02140151.

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 25 Aug 2022.

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