AzTrials
AzTrials

Neovascular Age-related Macular DegenerationPhase 2NCT03345082

A Dose Ranging Study of OPT-302 With Ranibizumab in Neovascular (Wet) AMD

A Phase 2 study testing OPT-302 and ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 108 sites in 10 countries.

Completed

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

Official record
Search all trials

Trial summary

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
OPT-302 and ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
366 participants
Where
108 sitesin 10 countries
Study dates
6 Nov 2017to 14 May 2019
Phase
Phase 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

  • Active subfoveal choroidal neovascular (CNV) lesion or juxtafoveal lesion secondary to age-related macular AMD
  • An ETDRS BCVA score between 60 and 25 (inclusive) letters

Who cannot join

  • Previous treatment for wet AMD or previous treatment for CNV due to other causes in the Study Eye
  • Clinically significant ocular disorders which may interfere with assessment of visual acuity, assessment of toxicity, or fundus photography in the Study Eye
  • Poorly controlled diabetes mellitus (defined as HbA1c>7%)
  • Any clinically significant cardiovascular, renal or hepatic conditions, recent surgery, or malignancy, that would make the participant unsuitable for the study

Trial locations and contacts

108 sites in 10 countries.

108 sites in 10 countries

United States55 sites

  • Opthea Investigational Site

    Abilene, Texas, 79606

  • Opthea Investigational Site

    Albuquerque, New Mexico, 87109

  • Opthea Investigational Site

    Asheville, North Carolina, 28803

  • Opthea Investigational Site

    Augusta, Georgia, 30909

  • Opthea Investigational Site

    Austin, Texas, 78705

  • Opthea Investigational Site

    Baltimore, Maryland, 21204

  • Opthea Investigational Site

    Beverly Hills, California, 90211

  • Opthea Investigational Site

    Boynton Beach, Florida, 33426

  • Opthea Investigational Site

    Camp Hill, Pennsylvania, 17011

  • Opthea Investigational Site

    Charlotte, North Carolina, 28210

  • Opthea Investigational Site

    Cleveland, Ohio, 44195

  • Opthea Investigational Site

    Colorado Springs, Colorado, 80909

  • Opthea Investigational Site

    Columbus, Ohio, 43212

  • Opthea Investigational Site

    Edison, New Jersey, 08820

  • Opthea Investigational Site

    Encino, California, 91436

  • Opthea Investigational Site

    Fairfax, Virginia, 22031

  • Opthea Investigational Site

    Fort Myers, Florida, 33907

  • Opthea Investigational Site

    Fort Myers, Florida, 33912

  • Opthea Investigational Site

    Golden, Colorado, 80401

  • Opthea Investigational Site

    Grand Rapids, Michigan, 49546

  • Opthea Investigational Site

    Houston, Texas, 77030

  • Opthea Investigational Site

    Kingston, Pennsylvania, 18704

  • Opthea Investigational Site

    Ladson, South Carolina, 29456

  • Opthea Investigational Site

    Las Vegas, Nevada, 89144

  • Opthea Investigational Site

    Lynbrook, New York, 11563

  • Opthea Investigational Site

    Melbourne, Florida, 32901

  • Opthea Investigational Site

    Paducah, Kentucky, 42001

  • Opthea Investigational Site

    Palm Desert, California, 92260

  • Opthea Investigational Site

    Pensacola, Florida, 32503

  • Opthea Investigational Site

    Philadelphia, Pennsylvania, 19107

  • Opthea Investigational Site

    Phoenix, Arizona, 85014

  • Opthea Investigational Site

    Phoenix, Arizona, 85020

  • Opthea Investigational Site

    Portland, Oregon, 97239

  • Opthea Investigational Site

    Redlands, California, 92374

  • Opthea Investigational Site

    Reno, Nevada, 89502

  • Opthea Investigational Site

    Rochester, New York, 14620

  • Opthea Study Site

    Sacramento, California, 95819

  • Opthea Investigational Site

    Sacramento, California, 95841

  • Opthea Investigational Site

    San Antonio, Texas, 78240

  • Opthea Investigational Site

    San Diego, California, 94143

  • Opthea Investigational Site

    Santa Ana, California, 92705

  • Opthea Investigational Site

    Santa Barbara, California, 93103

  • Opthea Investigational Site

    Santa Maria, California, 93454

  • Opthea Investigational Site

    Shawnee Mission, Kansas, 66204

  • Opthea Investigational Site

    Silverdale, Washington, 98383

  • Opthea Investigational Site

    St. Petersburg, Florida, 33703

  • Opthea Investigational Site

    Syracuse, New York, 13224

  • Opthea Investigational Site

    Tallahassee, Florida, 32308

  • Opthea Investigational Site

    Teaneck, New Jersey, 07666

  • Opthea Investigational Site

    The Woodlands, Texas, 77384

  • Opthea Investigational Site

    Virginia Beach, Virginia, 23462

  • Opthea Investigational Site

    West Columbia, South Carolina, 29169

  • Opthea Investigational Site

    Wichita, Kansas, 67214

  • Opthea Investigational Site

    Willow Park, Texas, 76087

  • Opthea Investigational Site

    Winter Haven, Florida, 33880

Other trials in United States

Israel8 sites

  • Opthea Investigational Site

    Haifa, 31048

  • Opthea Investigational Site

    Haifa

  • Opthea Investigational Site

    Jerusalem, 91031

  • Opthea Investigational Site

    Jerusalem

  • Opthea Investigational Site

    Kfar Saba

  • Opthea Investigational Site

    Petah Tikva

  • Opthea Investigational Site

    Rehovot

  • Opthea Investigational Site

    Tel Aviv

Other trials in Israel

Spain8 sites

  • Opthea Investigational Site

    Barcelona

  • Opthea Investigational Site

    Bilbao

  • Opthea Investigational Site

    Madrid

  • Opthea Investigational Site

    Oviedo

  • Opthea Investigational Site

    Pamplona

  • Opthea Investigational Site

    Santiago de Compostela

  • Opthea Investigational Site

    Valencia

  • Opthea Investigational Site

    Valladolid

Other trials in Spain

Poland7 sites

  • Opthea Investigational Site

    Bydgoszcz

  • Opthea Investigational Site

    Gdansk

  • Opthea Investigational Site

    Katowice

  • Opthea Investigational Site

    Krakow

  • Opthea Investigationa Site

    Lublin, 20079

  • Opthea Investigational Site

    Lublin

  • Opthea Investigational Site

    Wroclaw

Other trials in Poland

United Kingdom7 sites

  • Opthea Investigational Site

    Bristol

  • Opthea Investigational Site

    Frimley

  • Opthea Investigational Site

    Glasgow

  • Opthea Investigational Site

    London

  • Opthea Investigational Site

    Maidstone

  • Opthea Investigational Site

    Sheffield

  • Opthea Investigational Site

    Wolverhampton

Other trials in United Kingdom

France6 sites

  • Opthea Investigational Site

    Créteil, 94010

  • Opthea Investigational Site

    Dijon, 21079

  • Opthea Investigational Site

    Écully, 69130

  • Opthea Investigational Site

    Paris, 75010

  • Opthea Investigational Site

    Paris, 75019

  • Opthea Investigational Site

    Strasbourg, 67090

Other trials in France

Hungary5 sites

  • Opthea Investigational Site

    Budapest, 1062

  • Opthea Investigational Site

    Budapest, 1133

  • Opthea Investigational Site

    Budapest

  • Opthea Investigational Site

    Nyíregyháza

  • Opthea Investigational Site

    Szeged, 6720

Other trials in Hungary

Italy5 sites

  • Opthea Investigational Site

    Bologna, 40138

  • Opthea Investigational Site

    Florence, 50134

  • Opthea Investigational Site

    Milan, 20157

  • Opthea Investigational Site

    Milan

  • Opthea Investigational Site

    Roma, 00133

Other trials in Italy

Latvia4 sites

  • Opthea Investigational Site

    Jelgava

  • Opthea Investigational Site

    Riga, 1006

  • Opthea Investigational Site

    Riga, 1009

  • Opthea Investigational Site

    Riga

Other trials in Latvia

Czechia3 sites

  • Opthea Investigational Site

    Hradec Králové, 50005

  • Opthea Investigational Site

    Prague, 10034

  • Opthea Investigational Site

    Prague, 12808

Other trials in Czechia

About this study

Official title: A Dose-Ranging Study of Intravitreal OPT-302 in Combination With Ranibizumab, Compared With Ranibizumab Alone, in Participants With Neovascular Age-Related Macular Degeneration (Wet AMD)

A multicentre, randomised, parallel group, sham-controlled, double-masked, dose-ranging study, investigating two doses of OPT-302 in combination with ranibizumab compared with ranibizumab with sham, over six consecutive monthly dosing cycles in participants with neovascular (wet) AMD.

Being tested
OPT-302, ranibizumab, sham intravitreal injection

What participants receive

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

  • OPT-302Biological

    Intravitreal injection

  • ranibizumabBiological

    Also called Lucentis

    Intravitreal injection

  • sham intravitreal injectionOther

    Sham (mock) intravitreal injection

Study groups in NCT03345082
Study groupRoleWhat they receive
0.5 mg ranibizumab with 2.0 mg OPT-302Experimental0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
Receives: Biological: OPT-302; Biological: ranibizumab
0.5 mg ranibizumab with 0.5 mg OPT-302Experimental0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
Receives: Biological: OPT-302; Biological: ranibizumab
0.5 mg ranibizumab with shamSham comparator0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
Receives: Biological: ranibizumab; Other: sham intravitreal injection

What is being measured

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

  1. Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA)

    Measured: Baseline to Week 24

Secondary outcomes (5)

  1. Proportion of participants gaining 15 or more ETDRS BCVA letters

    Measured: Baseline to Week 24

  2. Area under the ETDRS BCVA over time curve

    Measured: Baseline to Week 24

  3. Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT)

    Measured: Baseline to Week 24

  4. Change in intra-retinal fluid and sub-retinal fluid on SD-OCT

    Measured: Baseline to Week 24

  5. Proportion of participants losing 15 or more letters (on ETDRS BCVA chart)

    Measured: Baseline to Week 24

Timeline

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

  1. First posted17 Nov 2017
  2. Study start6 Nov 2017
  3. Primary completion14 May 2019
  4. Study completion14 May 2019

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03345082
Sponsor's protocol ID
OPT-302-1002
Status last verified
Jan 2020
First submitted
14 Nov 2017
Last updated
12 Jan 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Jackson TL, Slakter J, Buyse M, Wang K, Dugel PU, Wykoff CC, Boyer DS, Gerometta M, Baldwin ME, Price CF; Opthea Study Group Investigators. A Randomized Controlled Trial of OPT-302, a VEGF-C/D Inhibitor for Neovascular Age-Related Macular Degeneration. Ophthalmology. 2023 Jun;130(6):588-597. doi: 10.1016/j.ophtha.2023.02.001. Epub 2023 Feb 6.

    PubMed 36754174

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OPT-302 and ranibizumab in people with Neovascular Age-related Macular Degeneration, run by Opthea Limited at 108 sites in 10 countries.

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 2 inclusion and 4 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 12 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 108 sites in United States, Israel, Spain, Poland, United Kingdom and 5 more countries. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this 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.

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?

Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) (time frame: Baseline to Week 24). 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 NCT03345082, 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 12 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in