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

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ClinicalTrials.gov Identifier: NCT03345082
Recruitment Status : Active, not recruiting
First Posted : November 17, 2017
Last Update Posted : November 28, 2018
Sponsor:
Information provided by (Responsible Party):
Opthea Limited

Brief 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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Biological: OPT-302 Biological: ranibizumab Other: sham intravitreal injection Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 6, 2017
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: 0.5 mg ranibizumab with 2.0 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 2.0 mg OPT-302 intravitreal injection (0.05 ml)
Biological: OPT-302
Intravitreal injection

Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis

Experimental: 0.5 mg ranibizumab with 0.5 mg OPT-302
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by 0.5 mg OPT-302 intravitreal injection (0.05 ml)
Biological: OPT-302
Intravitreal injection

Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis

Sham Comparator: 0.5 mg ranibizumab with sham
0.5 mg ranibizumab intravitreal injection (0.05 ml) followed by sham
Biological: ranibizumab
Intravitreal injection
Other Name: Lucentis

Other: sham intravitreal injection
Sham (mock) intravitreal injection




Primary Outcome Measures :
  1. Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. Proportion of participants gaining 15 or more ETDRS BCVA letters [ Time Frame: Baseline to Week 24 ]
  2. Area under the ETDRS BCVA over time curve [ Time Frame: Baseline to Week 24 ]
  3. Change in central subfield thickness (CST) on spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline to Week 24 ]
  4. Change in intra-retinal fluid and sub-retinal fluid on SD-OCT [ Time Frame: Baseline to Week 24 ]
  5. Proportion of participants losing 15 or more letters (on ETDRS BCVA chart) [ Time Frame: Baseline to Week 24 ]


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03345082


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Sponsors and Collaborators
Opthea Limited
Investigators
Study Director: Study Director Opthea Limited

Responsible Party: Opthea Limited
ClinicalTrials.gov Identifier: NCT03345082     History of Changes
Other Study ID Numbers: OPT-302-1002
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents