Branch Retinal Vein occlusion (BRVO)

Overview:
Laser: BVOS
Bevacizumab: PACORAS
Ranibizumab: BRAVO >  HORIZON > RETAIN, RELATE, BRIGHTER
Aflibercept: VIBRANT
Steroids: SCORE, Shasta, GENEVA, COMRADE-B, COMO



Branch Vein Occlusion Study (BVOS), 1986 ⏩
N=139, 3y
Study question: Macular Grid & sectorial PRP vs Observation for BRVO. 

Study Results: Observation: 60% returning to VA better than 6/12 within a year. After 3 years: 65% treated eyes gain 2 lines vs 37% untreated eyes. Average gain of 1.5 letters in the tx group 12% of tx eyes with VA 20/200 or worse. This study revealed the implications of "ischemic BRVO" (>5 DD of retinal CNP) with 40% of NV. 60% of  eyes with NV will experience VH.  60% of tx eyes had 20/40 or better vs 34% untreated eyes. Scatter reduced risk of VH from 60% to 30%. Preventive full PRP or scatter? No benefit.

Safety and efficacy of intravitreal ranibizumab (Lucentis) in patients with macular edema secondary to branch retinal vein occlusion (BRAVO), 2009 ⏩ and ⏩
n=397, 12mo
Study question: ME d/t BRVO: monthly injections - for 6 months - of ranibizumab (0.3mg or 0.5mg) vs sham. Then PRN. Results: Gained 16.6 letters in the 0.3mg arm, 18.3 letters in 0.5mg and 7.3 letters in the sham arm. Improvements from baseline are maintained with PRN. Only partial catch-up after later intervention. 50% less injections at PRN. ⅓ Needed laser despite inj. See extension-HORIZON study from 2012.


A Randomized Trial Comparing the Efficacy and Safety of Intravitreal Triamcinolone With Standard Care to Treat Vision Loss Associated With Macular Edema Secondary to Branch Retinal Vein Occlusion The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE), 2009 ⏩
N=411, 1y
Study question: Laser VS IVT triamcinolone 1mg VS 4mg for CME d/t BRVO
Results: Gained 15 ETDRS letters: 29% in laser, 27% for 1mg, 26% for 4mg, 7% observation.
No difference between laser and IVT steroid. Average 1.5 injections in 1 year.

Randomized, sham-controlled trial of dexamethasone intravitreal implant in patients with macular edema due to retinal vein occlusion (GENEVA study group), 2010 ⏩
n=1267, 6m
Study question: Dexamethasone intravitreal implant (OZURDEX) 0.7mg vs 0.35mg vs sham for macular edema d/2 BRVO (and CRVO).

Results: Improvement in BCVA was greater in both DEX implant groups compared with sham at all follow-up visits. IOP of > or =25 mmHg peaked at 16% at day 60 (both doses) and was not different from sham by day 180. No significant difference in secondary cataract. 12.5% had 10 mmH2O IOP elevation. VA improved as soon as 1 week. Peak effect and IOP at 8 weeks. Six month open label extension with 0.7mg implant PRN showed similar benefits and no significant change in risk of elevated IOP with second inj. Sham group improved with tx but were not able to fully catch up with earlier tx groups.



Comparison of two doses of intravitreal bevacizumab as primary treatment for macular edema secondary to branch retinal vein occlusions: results of the Pan American Collaborative Retina Study Group at 24 months (PACORAS), 2010 ⏩
n=63, 24m
Study question:  Bevacizumab 1.25 mg vs 2.5 mg for CME d/t BRVO. Retrospective study.
Study results: No statistically significant differences were found between the two dose groups with regard to the number of injections, CMT, and change in BCVA. Mean number of injections was 3.6 in the 1.25-mg group and 4.3 in the 2.5-mg group (P = 0.4). BCVA improved +0.38 letters vs 0.64 for the 2.5-mg group.


Ranibizumab for macular edema due to retinal vein occlusions: long-term follow-up in the HORIZON trial, 2012 ⏩ (there is a HORIZON for DME as well).
n=304 from CRUISE + 304 from BRAVO, 12mo
Study question: This is an extension of BRAVO and CRUISE see above. All patients on PRN of Ranibizumab q3m. Study results: Mean change from baseline BCVA letter score at month 12 in BRVO patients was 0.9 (sham/0.5 mg), -2.3 (0.3/0.5 mg), and -0.7 (0.5 mg). PRN at q3m yields stable VA in BRVO. No new safety issues.

Long-term Outcomes in Patients with Retinal Vein Occlusion Treated with Ranibizumab (RETAIN), 2014 ⏩
n=34 BVO, 32 CRVO. 2y extension. Mean-49m
Study Question: Pateints from BRAVO and CRUISE. Long term follow-up with Ranibizmab + Scatter. Study results:  50% had edema resolution, mean improvement in BCVA was 25.9 letters versus 17.1 in unresolved patients. Mean number of injections required in unresolved patients in year 4 was 3.2. Both groups ~80% had a final BCVA of 20/40 or better. Nine had scatter, one had resolution of edema.


Efficacy and safety of two or more dexamethasone intravitreal implant injections for treatment of macular edema related to retinal vein occlusion (Shasta study), 2014 ⏩
n=289, 3m s/p last injection
Study question: Retrospective study looking at efficacy of multiple ozurdex injections since SCORE patients had only 1-2. Study results: 2-9 injectiosn, mean 3.2. Mean interval 5.6 months. 59.7% of BRVO and 66.7% of CRVO gained ≥ 2-lines. IOP increase (≥ 10 mmHg) occurred in 32.6% of patients; 29.1% needed topical tx. 1.7% of patients required incisional glaucoma surgery


Efficacy and Safety of 0.5 mg Ranibizumab compared with 0.7 mg dexamethasone intravitreal implant in patients with branch retinal vein occlusion over 6 months: The COMRADE-B study, 2014 ⏩
n=244, 6m
Study question: 0.5mg Ranibizumab PRN after 3 monthly inj VS. 0.7mg Ozurdex in BRVO. Study results:  Mean BCVA letter gain was +16.18 Ranibizumab vs. +8.10 for Ozurdex. IOP rise in Ozurdex group. $ Novartis. See COMRADE C (for CRVO)


Scatter Photocoagulation Does Not Reduce Macular Edema or Treatment Burden in Patients with Retinal Vein Occlusion (RELATE), 2015 ⏩
CRVO n=39, BRVO n=42. 144w
Study question: Ranibizumab 0.5 or 2mg for 24w. 6 mandatory inj. Then PRN with Laser VS without laser. Study results: Dosage did not differ in VA. 2mg had better CMT. Laser did not effect burden or # inj, did cause elevation in CMT


Comparison of intravitreal dexamethasone implant and Ranibizumab for macular edema in BRVO (COMO), Unpublished ⏩
n=307, 12m
Study question: BRAVO showed the role of Ranibizumab and GENEVA showed the role of dexamethasone. COMO was a RCT Ranibizumab VS Ozurdex for CME d/t BRVO.
Study results: Never published but can be reviewed at clinicaltrials.gov. At 12m 16.9 letters gained in Ranibizumab vs 7.9 in the Ozurdex group. $ by Allergan.


Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: 52-Week Results (VIBRANT), 2016 ⏩ and ⏩
N=183, 12m
Study question: Aflibercept (q4w for 24w, then q8w) vs Grid. Study results: At week 24 15 ETDRS letters gain: 52% versus 26% in laser. At week 52: 57% vs 41% in laser. Mean change in VA: 17.1 versus 12.2 on the laser group. 10% of the aflibercept group needed rescue laser versus 80% of laser group.

Sustained Benefits of Ranibizumab with or without Laser in Branch Retinal Vein Occlusion: 24-Month Results (BRIGHTER Study), 2017 ⏩
n=380, 24m
Study question: Laser VS Ranibizumab 0.5 mg PRN VS combination for CME d/t BRVO. Individualized visual acuity (VA) stabilization criteria. Study results:  Gained BCVA letters: Ranibizumab alone +17.3, Laser and Ranibizumab from month 6-15.5 letters, Only laser +11.6. Laser did not reduce the number of inj (~11.4 both groups). Macular ischemia did not affect BCVA outcome or treatment frequency.



Abbreviations used on this page:
$ - Financial support, when relevant
BRVO - Branch retinal vein occlusion
CME - Central\cystoid macular edema

CNP - capillary non perfusion
CRVO - Central vein occlusion

DD - disc diameter
DEX - dexamethasone intravitreal implant (OZURDEX)
d/t = due to
ETDRS - Early treatment diabetic retinopathy
IVT - intravitreal

inj - injectiosn
ME - macular edema
mg - milligram
PRN - Pro re nata, monthly visits with injections as needed
PRP - Pan-retinal photocoagulation
RCT - Randomized controlled trial
VA - Visual acuity
VH - Vitreous Hemorrhage
tx - treatment

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