A Phase 3 interventional study of ranibizumab and Peripheral Laser in Retinal Vein Occlusion, sponsored by Peter A Campochiaro, MD. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-13.
Sponsored by Peter A Campochiaro, MD · Phase 3, Interventional, and Treatment
This study evaluates long-term safety in patients with macular edema due to Retinal Vein Occlusion (RVO) originally enrolled in the BRAVO \& CRUISE trials and subsequently followed in the HORIZON extension trial.
There is strong evidence that ranibizumab provides benefit in subjects with macular edema due to RVO; however, some subjects required continued injections for years to maintain those benefits. It is likely that such subjects have continued production of VEGF (Vascular Endothelial Growth Factor) from areas of nonperfused retina in the periphery. One strategy is to perform scatter photocoagulation to areas of nonperfusion to reduce continued production of VEGF, but it is important to know if visual benefits are maintained when this is done, because if it is not, it would be better to continue intermittent injections of ranibizumab.
841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.
This study's enrollment of 66 is above the median of 50 across 619 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Peter A Campochiaro, MD is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart; with optional peripheral laser to areas of non-perfusion.
Drug: ranibizumab · Other: Peripheral Laser
Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
Also known as: RBZ, lucentis
Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
Also known as: Laser
Incidence of Serious Adverse Events.
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
Time frame: 24 mos
Mean Changes in Visual Acuity
Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
Time frame: 24 mos from study baseline
Mean Change in Retinal Thickness
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
Time frame: 24 mos from study baseline
66 retinal vein occlusion patients from the HORIZON study(NCT01198327)were enrolled from 7 sites for long term follow up. The sites were: Wilmer Eye Institute, Ophthalmic Consultants of Boston, Retina Consultants of New Jersey, Retina Consultants Macula Group,Retina Consultants of Houston, Southeast Retina and Retina Vitreous Associates
| Milestone | Ranibizumab as Needed |
|---|---|
| Started | 66 |
| Completed | 56 |
| Not completed | 10 |
Record the serious adverse events, both ocular and non-ocular to gather long-term safety data.
| number of serious adverse events | Ranibizumab as Needed |
|---|---|
| Incidence of Serious Adverse Events. | 17 |
Mean changes in visual acuity. Visual acuity is measured using standard ETDRS (Early Treatment Diabetic Retinopathy Study) charts which measure visual acuity in terms of letters( ETDRS Letters) read at a distance of 4 meters away from the chart. The ETDRS letters Score can be from 0 to 100, with 0 representing poor vision and 100 representing best vision.
| ETDRS letters | Ranibizumab as Needed -CRVO | Ranibizumab as Needed -BRVO |
|---|---|---|
| Mean Changes in Visual Acuity | 14.0 ± 20.9 | 20.1 ± 17.2 |
Mean change in retinal thickness as measured by OCT (Optical Coherence Tomography).
| microns | Ranibizumab as Needed -CRVO | Ranibizumab as Needed -BRVO |
|---|---|---|
| Mean Change in Retinal Thickness | -426.0 ± 270.1 | -236.2 ± 230.3 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ranibizumab as Needed | — | 17/66 (25.8%) | 53/66 (80.3%) |
| Event | Ranibizumab as Needed |
|---|---|
| Hospitalized for pneumoniaInfections and infestations | 2/66 |
| Hospitalized for elective surgeryMusculoskeletal and connective tissue disorders | 2/66 |
| Death resulting from pre-existing idiopathic pulmonary fibrosisGeneral disorders | 1/66 |
| Death of unknown causeGeneral disorders | 1/66 |
| ECG for elective knee surgery showed inverted T waves, patient asymptomatic, admitted for workupCardiac disorders | 1/66 |
| Mild chest discomfort for 6 mos, coronary angiography showed 2 obstructionsCardiac disorders | 1/66 |
| Tachycardia and went to the emergency departmentCardiac disorders | 1/66 |
| Syncope with fall because of arrhythmiaCardiac disorders | 1/66 |
| Chronic atrial fibrillation, CVA; bladder cancer identified during hospitalizationGeneral disorders | 1/66 |
| Head injury resulting from fallGeneral disorders | 1/66 |
| Event | Ranibizumab as Needed |
|---|---|
| Upper Respiratory InfectionGeneral disorders | 20/66 |
| Ocular discomfortEye disorders | 13/66 |
| Subconjuctival HemorrhageEye disorders | 13/66 |
| Vitreous HemmorhageEye disorders | 7/66 |
| Age, Categorical(Participants) | Ranibizumab as Needed |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 23 |
| >=65 years | 43 |
| Age, Continuous(years) | Ranibizumab as Needed |
|---|---|
| Mean | 67.9 ± 10.8 |
| Sex: Female, Male(Participants) | Ranibizumab as Needed |
|---|---|
| Female | 28 |
| Male | 38 |
| Region of Enrollment(participants) | Ranibizumab as Needed |
|---|---|
| United States | 66 |
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Peter A Campochiaro, MD